Recall Z-1328-2025 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker Corporation
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
| Date | Mar 12, 2025 (initiated Jan 29, 2025) |
| Status | Open, Classified |
| Reason | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 9521 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151314 | CinchLock Flex Knotless Suture Anchor Pivot Medical, Jul 23, 2015 |