Memphis, TN, United States
Smith & Nephew, Inc. recalls
64 recalls recorded since 2018, most recently on 16 March 2026. 26 are listed as ongoing. Status and classification are as published by the FDA.
Recalls64
Ongoing (FDA)26
Terminated or completed38
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 March 2026
- Reason
- Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
- Distribution
- International distribution to the countries of BE, DE, IT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2456-2026
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Ongoing Class II Medical devices
- Recall started
- 24 November 2025
- Reason
- Removal of affected lot of screws due to labeling error.
- Distribution
- US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0957-2026
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Ongoing Class II Medical devices
- Recall started
- 18 March 2025
- Reason
- Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1806-2025
- META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Ongoing Class II Medical devices
- Recall started
- 29 October 2024
- Reason
- Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0581-2025
- BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Ongoing Class II Medical devices
- Recall started
- 15 October 2024
- Reason
- The Bipolar assembly contains an oversized Retainer Ring.
- Distribution
- International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0326-2025
- Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Ongoing Class II Medical devices
- Recall started
- 2 October 2024
- Reason
- Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- Distribution
- US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0278-2025, Z-0277-2025
- smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
- smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Ongoing Class II Medical devices
- Recall started
- 2 October 2024
- Reason
- Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
- Distribution
- US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0282-2025, Z-0281-2025
- smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
- smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Ongoing Class II Medical devices
- Recall started
- 12 August 2024
- Reason
- Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Swi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3097-2024, Z-3096-2024
- ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
- ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
Ongoing Class II Medical devices
- Recall started
- 9 July 2024
- Reason
- Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
- Distribution
- US, Canada, Norway
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3171-2024, Z-3172-2024
- DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
- DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Ongoing Class II Medical devices
- Recall started
- 24 April 2024
- Reason
- Packaging contained the incorrect size of femoral head from what was displayed on the label.
- Distribution
- International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1901-2024
- smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Ongoing Class II Medical devices
- Recall started
- 27 September 2023
- Reason
- The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
- Distribution
- Worldwide distribution - US Nationwide and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0158-2024, Z-0157-2024
- JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
- JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Ongoing Class II Medical devices
- Recall started
- 31 August 2023
- Reason
- The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
- Distribution
- OH, CT, TX, NC, CA, NE, NV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2621-2023
- smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Ongoing Class II Medical devices
- Recall started
- 24 July 2023
- Reason
- A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
- Distribution
- US, AE, CA, DE, ES, GB, MX, PA, PL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2443-2023, Z-2444-2023
- TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
- TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Ongoing Class II Medical devices
- Recall started
- 2 May 2023
- Reason
- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1671-2023, Z-1670-2023, Z-1672-2023, Z-1673-2023
- Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
- Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Med
- Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF
- Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11M
Ongoing Class II Medical devices
- Recall started
- 27 March 2023
- Reason
- A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1393-2023
- JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Terminated Class II Medical devices
- Recall started
- 27 June 2022
- Terminated
- 25 March 2026
- Reason
- The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1418-2022
- (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Terminated Class II Medical devices
- Recall started
- 19 April 2022
- Terminated
- 16 August 2024
- Reason
- It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1099-2022
- LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Ongoing Class II Medical devices
- Recall started
- 4 January 2022
- Reason
- The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
- Distribution
- US Nationwide distribution in the states of CA and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0548-2022
- INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Ongoing Class II Medical devices
- Recall started
- 14 December 2021
- Reason
- Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0635-2022
- Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Terminated Class II Medical devices
- Recall started
- 1 November 2021
- Terminated
- 15 June 2026
- Reason
- Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
- Distribution
- US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0363-2022, Z-0365-2022, Z-0366-2022, Z-0364-2022
- smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
- smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
- smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
- smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
Ongoing Class II Medical devices
- Recall started
- 25 October 2021
- Reason
- The labels on the packages of screws were switched.
- Distribution
- Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0265-2022
- Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Terminated Class II Medical devices
- Recall started
- 20 September 2021
- Terminated
- 24 March 2023
- Reason
- The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0143-2022
- 6.5MMX165MM CANNULATED SCREW
Terminated Class II Medical devices
- Recall started
- 19 May 2021
- Terminated
- 14 April 2023
- Reason
- The device components experienced a manufacturing process error that resulted in surface damage from product handling.
- Distribution
- US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1951-2021
- LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Terminated Class II Medical devices
- Recall started
- 8 April 2021
- Terminated
- 22 June 2022
- Reason
- Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1510-2021
- CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
Terminated Class II Medical devices
- Recall started
- 18 December 2020
- Terminated
- 1 May 2023
- Reason
- Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0933-2021
- VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. V
Terminated Class II Medical devices
- Recall started
- 2 November 2020
- Terminated
- 6 January 2023
- Reason
- Manufacturing packaging error.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0772-2021
- Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental s
Terminated Class II Medical devices
- Recall started
- 21 September 2020
- Terminated
- 22 March 2024
- Reason
- The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
- Distribution
- Domestic Distribution: CA, CO, CT, GA, IA, IL, IN, MD, MO, NC, NY, OH, PA, SC, TN, TX, WA, WI, WV. International Distribution: AU, BR, CA, CL, CN, CO, DE, ES, GB, HK, KR, PA, PT, TW.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0301-2021
- 5.5MM Arthrogarde Hip Access Cannula
Terminated Class II Medical devices
- Recall started
- 21 September 2020
- Terminated
- 22 May 2026
- Reason
- The anterior locking detail does not meet its design specifications.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0118-2021
- Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collat
Ongoing Class II Medical devices
- Recall started
- 9 September 2020
- Reason
- Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Distribution
- Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0150-2021, Z-0137-2021, Z-0136-2021, Z-0160-2021, Z-0154-2021, Z-0165-2021, Z-0175-2021, Z-0143-2021, Z-0153-2021, Z-0138-2021, Z-0149-2021, Z-0145-2021 and 28 more
- OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
- TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
- TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
- TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
- OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
- OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
- MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
- ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
- and 32 more product lines
Terminated Class II Medical devices
- Recall started
- 24 August 2020
- Terminated
- 11 July 2022
- Reason
- Multiple or incorrect expiration dates were provided on the affected designation labels.
- Distribution
- International Distribution to the countries of Denmark, Sweden, France and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2945-2020
- EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
Terminated Class II Medical devices
- Recall started
- 3 August 2020
- Terminated
- 10 September 2026
- Reason
- The products were improperly heat treated.
- Distribution
- US states: CA CO CT GA HI IL IN KY MA MD NC NY OK PA SD TN WA WI OUS countries: AE CO JP KR PL ZA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2818-2020
- Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Ongoing Class II Medical devices
- Recall started
- 16 July 2020
- Reason
- Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
- Distribution
- Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO. International Distribution: Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Check Republic, Denmark, Spain, France, Great Bri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2774-2020
Terminated Class II Medical devices
- Recall started
- 29 June 2020
- Terminated
- 18 February 2022
- Reason
- The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
- Distribution
- U.S Nationwide including in the states of IN and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2777-2020
- PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of p
Terminated Class II Medical devices
- Recall started
- 24 June 2020
- Terminated
- 28 April 2021
- Reason
- A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
- Distribution
- International distribution in the countries of Brazil, Colombia and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2685-2020
- TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Ongoing Class II Medical devices
- Recall started
- 24 June 2020
- Reason
- A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
- Distribution
- Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore Sout
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2746-2020
- SUTUREFIX ULTRA Suture, Product number 72203855
Ongoing Class II Medical devices
- Recall started
- 24 June 2020
- Reason
- The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
- Distribution
- Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT. Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT, & ZA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2702-2020
- Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
Ongoing Class II Medical devices
- Recall started
- 22 April 2020
- Reason
- A manufacturing error resulted in out of specification R3 Acetabular Shells
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2334-2020, Z-2331-2020, Z-2335-2020, Z-2332-2020, Z-2336-2020, Z-2333-2020
- smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 713
- smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM
- smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668
- smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 7133
- smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 713
- smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52M
Ongoing Class II Medical devices
- Recall started
- 17 March 2020
- Reason
- Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.
- Distribution
- Nationwide Foreign: AE AL AR AT AU BE BM BR CA CH CL CN CO CR CZ DE DK EC EE ES FI FR GB IE IL IN IT KR LT LV MT MX NO PA PE PL PR PT QA RU SE SG TH TR XK ZA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1757-2020, Z-1756-2020
- Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
- Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
Terminated Class II Medical devices
- Recall started
- 27 February 2020
- Terminated
- 2 August 2024
- Reason
- Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
- Distribution
- Nationwide distribution to AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, LA, MA, MI, MN, MS, MT, NC, NJ, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV. International distribution to Turkey, United Kingdom, Thailand, Switzerland, France, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1634-2020
- NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and
Terminated Class II Medical devices
- Recall started
- 28 January 2020
- Terminated
- 11 December 2023
- Reason
- The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2132-2020, Z-2133-2020
- JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and
- JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and
Terminated Class II Medical devices
- Recall started
- 30 December 2019
- Terminated
- 11 May 2021
- Reason
- Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
- Distribution
- Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1273-2020
- TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Terminated Class II Medical devices
- Recall started
- 19 December 2019
- Terminated
- 4 September 2024
- Reason
- LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
- Distribution
- USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1507-2020
- LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Ongoing Class II Medical devices
- Recall started
- 16 December 2019
- Reason
- Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
- Distribution
- USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0878-2020
- LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical inst
Terminated Class II Medical devices
- Recall started
- 11 November 2019
- Terminated
- 7 May 2021
- Reason
- There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0696-2020
- smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
Terminated Class II Medical devices
- Recall started
- 7 October 2019
- Terminated
- 8 March 2023
- Reason
- LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
- Distribution
- Worldwide distributions - US Nationwide distributions and countries of Belgium, Brazil, China, Columbia, France, Great Britain, India, Japan, Russia, Singapore, South Africa, Spain,and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0351-2020
- LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, lo
Terminated Class II Medical devices
- Recall started
- 19 February 2019
- Terminated
- 21 May 2021
- Reason
- Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
- Distribution
- US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1029-2019, Z-1028-2019
- smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
- smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Terminated Class II Medical devices
- Recall started
- 7 January 2019
- Terminated
- 17 September 2020
- Reason
- The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
- Distribution
- NY, TN, Germany, Italy, Great Britain, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0730-2019
- SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Terminated Class II Medical devices
- Recall started
- 10 December 2018
- Terminated
- 3 November 2020
- Reason
- Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
- Distribution
- US Distribution to OR and TN; and Internationally to: Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1043-2019, Z-1045-2019, Z-1044-2019, Z-1042-2019
- JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial bas
- JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial bas
- JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial bas
- JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial bas
Terminated Class II Medical devices
- Recall started
- 18 September 2018
- Terminated
- 8 May 2019
- Reason
- One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
- Distribution
- US Distribution to the states of: KS and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0200-2019
- Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to pre
Ongoing Class II Medical devices
- Recall started
- 13 June 2018
- Reason
- The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.
- Distribution
- Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0003-2019, Z-0002-2019, Z-0001-2019
- JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 7402313
- JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 7402112
- Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225,
Terminated Class II Medical devices
- Recall started
- 11 May 2018
- Terminated
- 5 April 2019
- Reason
- The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
- Distribution
- OH, TX, CO, TN, MI, PA, NJ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2268-2018, Z-2267-2018
- Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62
- Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Terminated Class II Medical devices
- Recall started
- 4 May 2018
- Terminated
- 22 February 2019
- Reason
- One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
- Distribution
- International only: United Arab Emirates, Spain, Mexico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2163-2018
- smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Terminated Class II Medical devices
- Recall started
- 2 May 2018
- Terminated
- 1 September 2020
- Reason
- Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1921-2018
- smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Terminated Class II Medical devices
- Recall started
- 9 April 2018
- Terminated
- 22 February 2019
- Reason
- A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
- Distribution
- US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1902-2018
- smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerat
Terminated Class II Medical devices
- Recall started
- 30 March 2018
- Terminated
- 21 August 2019
- Reason
- The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- Distribution
- US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1906-2018, Z-1904-2018, Z-1905-2018, Z-1907-2018
- smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent
- smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent
- smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent
- smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent a
Terminated Class II Medical devices
- Recall started
- 7 March 2018
- Terminated
- 31 October 2018
- Reason
- One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
- Distribution
- US, Puerto Rico, Malaysia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1317-2018
- D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
Terminated Class II Medical devices
- Recall started
- 1 February 2018
- Terminated
- 22 October 2018
- Reason
- The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
- Distribution
- Worldwide Distribution - US Distribution to the states of: NY, IL, NJ, TX, CO, and to the countries of : Belgium, Great Britain, Australia, Germany, Netherlands, Norway.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1105-2018
- smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthri
Completed Class II Medical devices
- Recall started
- 15 January 2018
- Reason
- The affected products were inadvertently packaged with an incorrect screw component.
- Distribution
- Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2538-2019
- LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior c
Terminated Class II Medical devices
- Recall started
- 13 December 2017
- Terminated
- 5 October 2020
- Reason
- In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0409-2018
- Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fix
Terminated Class II Medical devices
- Recall started
- 11 December 2017
- Terminated
- 22 June 2018
- Reason
- Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
- Distribution
- US Distribution to states of: MI, GA, and OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0397-2018, Z-0396-2018
- smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and b
- smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone s
Terminated Class II Medical devices
- Recall started
- 11 December 2017
- Terminated
- 21 September 2020
- Reason
- Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
- Distribution
- Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1536-2018
- Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Terminated Class II Medical devices
- Recall started
- 29 November 2017
- Terminated
- 1 September 2020
- Reason
- One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
- Distribution
- US Distribution to the state of OR, and Internationally to Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0408-2018
- smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System
Terminated Class II Medical devices
- Recall started
- 23 October 2017
- Terminated
- 24 August 2018
- Reason
- The expiration date provided on the label is incorrect.
- Distribution
- Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0406-2018
- Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Terminated Class II Medical devices
- Recall started
- 1 August 2017
- Terminated
- 19 February 2019
- Reason
- Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
- Distribution
- Australia, Austria, Germany, Great Britain, Poland, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2883-2018
- GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
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.