Portage, MI, United States
Stryker Instruments Div. of Stryker Corporation recalls
12 recalls recorded since 2018, most recently on 15 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)0
Terminated or completed12
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 15 June 2022
- Terminated
- 5 April 2024
- Reason
- When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
- Distribution
- The products were distributed to the following US states: KS and ME.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1452-2022
- SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Terminated Class II Medical devices
- Recall started
- 16 October 2020
- Terminated
- 22 June 2022
- Reason
- Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
- Distribution
- Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0431-2021
- Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-06
Terminated Class II Medical devices
- Recall started
- 26 March 2020
- Terminated
- 15 July 2020
- Reason
- Due to a distribution error, product from the affected lot was shipped expired.
- Distribution
- International distribution the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1807-2020
- Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting an
Terminated Class II Medical devices
- Recall started
- 22 January 2020
- Terminated
- 29 January 2024
- Reason
- Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1402-2022
- Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used w
Terminated Class II Medical devices
- Recall started
- 13 January 2020
- Terminated
- 10 August 2021
- Reason
- Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1097-2020, Z-1099-2020, Z-1098-2020
- SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
- Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
- Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Terminated Class II Medical devices
- Recall started
- 6 November 2019
- Terminated
- 19 November 2021
- Reason
- There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
- Distribution
- Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0593-2020, Z-0592-2020
- Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indic
- Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is ind
Terminated Class II Medical devices
- Recall started
- 31 July 2019
- Terminated
- 24 March 2021
- Reason
- Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0024-2020, Z-0023-2020
- C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and p
- C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and p
Terminated Class II Medical devices
- Recall started
- 19 March 2019
- Terminated
- 26 June 2020
- Reason
- During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
- Distribution
- US Nationwide in the states of: FL, GA, ID, KY, MA, MD, MN, NC, PA, UT, WA, and WI. The products were distributed to the following foreign countries: Canada, France, Italy, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1215-2019
- Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic pro
Terminated Class III Medical devices
- Recall started
- 4 December 2018
- Terminated
- 11 March 2024
- Reason
- Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1394-2022
- Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Terminated Class II Medical devices
- Recall started
- 23 February 2018
- Terminated
- 23 May 2019
- Reason
- Separation of material layers may occur, causing a potential risk of exposure to contaminants.
- Distribution
- US Nationwide and Ireland, Japan, South Korea, UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1505-2018, Z-1509-2018, Z-1510-2018, Z-1501-2018, Z-1508-2018, Z-1506-2018, Z-1504-2018, Z-1500-2018, Z-1502-2018, Z-1503-2018, Z-1507-2018
- T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
- T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
- T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
- T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
- T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
- T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
- T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
- T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 9 November 2017
- Terminated
- 16 April 2019
- Reason
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Distribution
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1252-2018, Z-1255-2018, Z-1249-2018, Z-1247-2018, Z-1253-2018, Z-1254-2018, Z-1248-2018, Z-1245-2018, Z-1243-2018, Z-1250-2018, Z-1251-2018, Z-1246-2018 and 1 more
- Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
- Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
- PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
- 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
- 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
- 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
- Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
- 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 16 October 2017
- Terminated
- 3 April 2019
- Reason
- Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.
- Distribution
- International , US and US Govt.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1216-2018
- The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely con
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.