Stryker Corporation 2025-03-19 Health serious FDA
Health · FDA · Recall #FDA-Z-1328-2025
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile… Recall
Issued March 19, 2025 · Stryker Corporation
In March 2025, Stryker Corporation recalled the Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
What you should do
- 1 Stop using Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Stryker Corporation
- Category
- Health
- Recall date
- March 19, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Del
- Recall number
- FDA-Z-1328-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Corporation has 15 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.