Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Recall
- Recall Number
- Z-1328-2025
- Event Number
- 96281
- Firm
- Stryker Corporation
- FEI Number
- 2936485
- Product Code
- MBI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 29, 2025
- Posted
- March 12, 2025
- Address
- 5900 Optical Ct, San Jose, CA, 95138-1400
Description
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
On January 29, 2025, Stryker issued a "Urgent Medical Device Recall " notification to affected consignees via: certified mail. Stryker ask consignees to take the following actions: Inform individuals within your organization who need to be aware of this device recall. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your account. Response is required by January 30, 2026. 3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the Business Reply Form (page 3) of this notice and return devices back to Stryker Endoscopy. a. Please call Customer Service at (800)624-4422 or email [email protected] to arrange for product return and issuance of credit or replacement (upon availability). 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. 5. If no product is found, complete the acknowledgement form and return it back to Stryker via email to [email protected].
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, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, Brazil.
9521 units