Portage, MI, United States

Stryker Corporation recalls

57 recalls recorded since 2018, most recently on 1 July 2026. 37 are listed as ongoing. Status and classification are as published by the FDA.

Recalls57

Ongoing (FDA)37

Terminated or completed20

Class I (FDA)0

Ongoing Class II Medical devices

Recall started: 1 July 2026
Reason: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Denmark, France, Germany, Greece, Ireland, I
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2828-2026, Z-2831-2026, Z-2827-2026, Z-2832-2026, Z-2833-2026, Z-2829-2026, Z-2830-2026

Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.

Ongoing Class II Medical devices

Recall started: 8 June 2026
Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2864-2026, Z-2862-2026, Z-2865-2026, Z-2863-2026, Z-2866-2026

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540

Ongoing Class II Medical devices

Recall started: 6 May 2026
Reason: It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
Distribution: US Nationwide distribution in the state of Indiana.
Initiated: Voluntary: Firm initiated
Recall number: Z-2282-2026

Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System

Ongoing Class II Medical devices

Recall started: 9 April 2026
Reason: Due to nonconforming products being inadvertently distributed.
Distribution: U.S. Nationwide distribution in the state of GA.
Initiated: Voluntary: Firm initiated
Recall number: Z-2166-2026

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid war

Ongoing Class II Medical devices

Recall started: 21 January 2026
Reason: Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panam
Initiated: Voluntary: Firm initiated
Recall number: Z-1427-2026

MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850

Ongoing Class II Medical devices

Recall started: 31 October 2025
Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0601-2026, Z-0599-2026, Z-0600-2026

NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Ho
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP;
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Ongoing Class II Medical devices

Recall started: 2 July 2025
Reason: Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Distribution: Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom
Initiated: Voluntary: Firm initiated
Recall number: Z-2277-2025

Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235

Ongoing Class II Medical devices

Recall started: 18 June 2025
Reason: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2171-2025, Z-2170-2025

Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

Ongoing Class II Medical devices

Recall started: 28 May 2025
Reason: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Distribution: Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Initiated: Voluntary: Firm initiated
Recall number: Z-1914-2025

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Ongoing Class II Medical devices

Recall started: 22 May 2025
Reason: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Distribution: Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1939-2025, Z-1940-2025

Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.

Ongoing Class II Medical devices

Recall started: 28 March 2025
Reason: The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Distribution: US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1620-2025, Z-1621-2025

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

Ongoing Class II Medical devices

Recall started: 25 February 2025
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1472-2025, Z-1476-2025, Z-1475-2025, Z-1477-2025, Z-1482-2025, Z-1471-2025, Z-1481-2025, Z-1473-2025, Z-1470-2025, Z-1478-2025, Z-1479-2025, Z-1474-2025 and 2 more

Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
and 6 more product lines

Ongoing Class II Medical devices

Recall started: 29 January 2025
Reason: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Monta
Initiated: Voluntary: Firm initiated
Recall number: Z-1328-2025

Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

Ongoing Class II Medical devices

Recall started: 8 January 2025
Reason: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1139-2025, Z-1138-2025

stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

Ongoing Class II Medical devices

Recall started: 3 December 2024
Reason: Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
Distribution: US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-0807-2025

100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)

Ongoing Class II Medical devices

Recall started: 4 October 2024
Reason: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0365-2025, Z-0369-2025, Z-0367-2025, Z-0366-2025, Z-0368-2025, Z-0370-2025

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when us
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery whe
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurg
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosur
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurger

Ongoing Class II Medical devices

Recall started: 5 September 2024
Reason: May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
Initiated: Voluntary: Firm initiated
Recall number: Z-0063-2025

1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental,

Completed Class II Medical devices

Recall started: 24 July 2024
Reason: Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2727-2024, Z-2724-2024, Z-2729-2024, Z-2725-2024, Z-2731-2024, Z-2728-2024, Z-2726-2024, Z-2723-2024, Z-2722-2024, Z-2730-2024

Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications:
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; S
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications:
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro;
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications:
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications:
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; S
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro;
and 2 more product lines

Ongoing Class II Medical devices

Recall started: 3 June 2024
Reason: Expired Products distributed to customers
Distribution: US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2259-2024, Z-2261-2024, Z-2260-2024

The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securel
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannu
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone c

Ongoing Class II Medical devices

Recall started: 9 May 2024
Reason: The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-2219-2024

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

Ongoing Class II Medical devices

Recall started: 6 December 2023
Reason: The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Distribution: US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1085-2024, Z-1084-2024

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

Ongoing Class II Medical devices

Recall started: 13 September 2023
Reason: Expired product distributed
Distribution: US: NH, TX, NY, NJ, OH, MN OUS: None
Initiated: Voluntary: Firm initiated
Recall number: Z-0287-2024

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access

Ongoing Class II Medical devices

Recall started: 11 September 2023
Reason: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Distribution: US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0244-2024, Z-0239-2024, Z-0240-2024, Z-0248-2024, Z-0257-2024, Z-0249-2024, Z-0250-2024, Z-0243-2024, Z-0253-2024, Z-0251-2024, Z-0241-2024, Z-0255-2024 and 7 more

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
and 11 more product lines

Ongoing Class II Medical devices

Recall started: 23 August 2023
Reason: Expired Product distributed
Distribution: US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
Initiated: Voluntary: Firm initiated
Recall number: Z-2645-2023

Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

Ongoing Class II Medical devices

Recall started: 7 August 2023
Reason: Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
Distribution: Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2598-2023, Z-2596-2023, Z-2597-2023, Z-2602-2023, Z-2601-2023, Z-2599-2023, Z-2600-2023

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-70
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000

Ongoing Class II Medical devices

Recall started: 10 July 2023
Reason: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2463-2023

SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures

Ongoing Class II Medical devices

Recall started: 28 June 2023
Reason: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
Distribution: Worldwide distribution - US Nationwide and the countries of UK, Netherlands, New Zealand.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0981-2025, Z-0982-2025

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

Ongoing Class II Medical devices

Recall started: 28 June 2023
Reason: There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
Distribution: Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Initiated: Voluntary: Firm initiated
Recall number: Z-0980-2025

The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neuro

Ongoing Class II Medical devices

Recall started: 2 March 2023
Reason: Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
Distribution: Worldwide - US Nationwide distribution including in the states of PA, MS, IL, OH, CA, TX, MO, IN, KS, OK, MT, MA, NE, AZ, NV, NJ, IA, WV, MD, KY, FL, NM, NY, CO, WA, NC, VA, LA, ND, WY, HI SC, UT, OR, SD, AR, TN, AK, CT, GA, ID, VT, NH, MN, WI, DE, RI, AL, MI and the countries of NL, PE, AT, CA, TW,
Initiated: Voluntary: Firm initiated
Recall number: Z-1474-2023

SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

Ongoing Class II Medical devices

Recall started: 1 March 2023
Reason: Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1339-2023, Z-1340-2023, Z-1343-2023, Z-1341-2023, Z-1342-2023, Z-1344-2023

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a pa
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a

Ongoing Class II Medical devices

Recall started: 7 February 2023
Reason: Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1191-2023

stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved

Ongoing Class II Medical devices

Recall started: 25 January 2023
Reason: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1186-2023, Z-1185-2023, Z-1184-2023

Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.

Ongoing Class II Medical devices

Recall started: 28 March 2022
Reason: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
Distribution: Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-1011-2022

Smart Toe II Intramedullary Arthrodesis Implant

Ongoing Class II Medical devices

Recall started: 14 January 2022
Reason: A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.
Distribution: Worldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL, IN, FR, ES, HK, IT, GB, CO, PE, MY, TH, CA, JP, MX, AR, NP, SG, PH, ZA, CL, KR, CN
Initiated: Voluntary: Firm initiated
Recall number: Z-0728-2022

1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.

Ongoing Class II Medical devices

Recall started: 27 May 2021
Reason: The devices have a different inner diameter than the diameter specified on the outer box label.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2170-2021, Z-2171-2021

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S

Terminated Class II Medical devices

Recall started: 26 February 2021
Terminated: 15 December 2023
Reason: Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW.
Initiated: Voluntary: Firm initiated
Recall number: Z-1428-2021

Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging

Ongoing Class II Medical devices

Recall started: 25 September 2020
Reason: The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
Distribution: The devices were distributed nationwide throughout the US, and to countries OUS. Easy Clip devices: As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in t
Initiated: Voluntary: Firm initiated
Recall number: Z-0457-2021

Osteosynthesis Compression Staple EasyClip

Terminated Class II Medical devices

Recall started: 7 May 2020
Terminated: 21 September 2023
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembour
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2374-2020, Z-2383-2020, Z-2380-2020, Z-2375-2020, Z-2387-2020, Z-2384-2020, Z-2379-2020, Z-2377-2020, Z-2378-2020, Z-2381-2020, Z-2386-2020, Z-2382-2020 and 3 more

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
and 7 more product lines

Ongoing Class II Medical devices

Recall started: 7 January 2020
Reason: Sterile drapes packaged in an unsealed pouch.
Distribution: US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Mala
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1925-2020, Z-1926-2020

Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326

Terminated Class II Medical devices

Recall started: 5 December 2019
Terminated: 9 October 2020
Reason: Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
Distribution: Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.
Initiated: Voluntary: Firm initiated
Recall number: Z-0780-2020

Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050

Terminated Class II Medical devices

Recall started: 21 November 2019
Terminated: 13 November 2020
Reason: Pin To Rod Coupling could not clamp the pin and rod as intended
Distribution: Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.
Initiated: Voluntary: Firm initiated
Recall number: Z-0781-2020

Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Interca

Terminated Class II Medical devices

Recall started: 12 September 2019
Terminated: 31 October 2022
Reason: Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
Distribution: OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1509-2020, Z-1508-2020

Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, Stry

Terminated Class II Medical devices

Recall started: 25 July 2019
Terminated: 24 September 2020
Reason: The seal integrity of the sterile bag containing the kits may be compromised.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2412-2019, Z-2418-2019, Z-2416-2019, Z-2419-2019, Z-2417-2019, Z-2423-2019, Z-2424-2019, Z-2413-2019, Z-2414-2019, Z-2415-2019, Z-2422-2019, Z-2421-2019 and 1 more

Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). Th
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis
Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). Th
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasci
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (
Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasc
Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis).
and 5 more product lines

Terminated Class II Medical devices

Recall started: 19 July 2019
Terminated: 2 February 2024
Reason: Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
Distribution: US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1148-2020, Z-1147-2020

Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197

Terminated Class II Medical devices

Recall started: 30 April 2019
Terminated: 18 September 2020
Reason: The seal integrity of the sterile bag containing the kits may be compromised.
Distribution: The products were distributed US nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1849-2019, Z-1848-2019

Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1

Terminated Class II Medical devices

Recall started: 23 April 2019
Terminated: 3 June 2021
Reason: There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury.
Distribution: Worldwide distribution - US Nationwide distribution in the states of GA, TX and countries of Canada, Singapore, Thailand, Malaysia. No US Govt.
Initiated: Voluntary: Firm initiated
Recall number: Z-1445-2020

Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grad

Terminated Class II Medical devices

Recall started: 7 March 2019
Terminated: 8 March 2024
Reason: The heated tube sets were consistently leaking and detaching from the cassette.
Distribution: Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Ur
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1726-2019, Z-1727-2019, Z-1728-2019

Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Terminated Class II Medical devices

Recall started: 21 January 2019
Terminated: 2 April 2020
Reason: The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
Distribution: In the countries of Canada and Korea
Initiated: Voluntary: Firm initiated
Recall number: Z-0980-2019

Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty

Terminated Class II Medical devices

Recall started: 28 August 2018
Terminated: 4 February 2021
Reason: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
Distribution: US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0291-2019, Z-0289-2019, Z-0290-2019, Z-0288-2019

Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed frac
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed frac
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed frac
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fract

Terminated Class II Medical devices

Recall started: 26 July 2018
Terminated: 26 May 2020
Reason: When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-3240-2018

Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Terminated Class II Medical devices

Recall started: 27 June 2018
Terminated: 13 April 2020
Reason: Incomplete seal on the Tyvek lid may compromise the sterility of the device
Distribution: US distribution to KY
Initiated: Voluntary: Firm initiated
Recall number: Z-2884-2018

Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 28

Terminated Class II Medical devices

Recall started: 4 May 2018
Terminated: 27 April 2020
Reason: Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
Distribution: AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
Initiated: Voluntary: Firm initiated
Recall number: Z-2244-2018

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Terminated Class II Medical devices

Recall started: 27 April 2018
Terminated: 21 May 2020
Reason: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Distribution: The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2394-2018, Z-2407-2018, Z-2399-2018, Z-2400-2018, Z-2404-2018, Z-2406-2018, Z-2408-2018, Z-2395-2018, Z-2397-2018, Z-2402-2018, Z-2398-2018, Z-2405-2018 and 4 more

Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
and 8 more product lines

Terminated Class II Medical devices

Recall started: 12 March 2018
Terminated: 21 May 2020
Reason: The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Distribution: USA (nationwide) Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-1526-2018

Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and a

Ongoing Class II Medical devices

Recall started: 25 January 2018
Reason: The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
Distribution: Netherlands
Initiated: Voluntary: Firm initiated
Recall number: Z-0974-2018

CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine typ

Completed Class II Medical devices

Recall started: 21 December 2017
Reason: Inadvertent shipment of expired units.
Distribution: US distribution to Massachusetts only..
Initiated: Voluntary: Firm initiated
Recall number: Z-2057-2018

3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.

Terminated Class II Medical devices

Recall started: 17 November 2017
Terminated: 29 January 2024
Reason: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0837-2018, Z-0836-2018, Z-0838-2018, Z-0835-2018

STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I T

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.