Drug recall
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE…
FDA recall event 96281 · Class II · Stryker Corporation
Key facts
| Event ID | 96281 |
|---|---|
| Recall numbers | Z-1328-2025 |
| Recalling firm | Stryker Corporation |
| Product type | Devices |
| Products | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. |
| Initiation date | Jan 29, 2025 |
| Report date | Mar 19, 2025 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 2936485 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: