CinchLock Flex Knotless Anchor with Inserter — Class II medical device recall Z-1635-2016
Terminated recall by Stryker Corporation, reported 2016-05-18, distributed nationwide. Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor wi
| Recall number | Z-1635-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2016-04-12 |
| Classified | 2016-05-10 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2016-12-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, ES, NL, SE |
| Quantity | 3,100 devices |
| Serial numbers | 15122202, 16011301, 16020802 |
| Model numbers | 02462, 02463, 02643 |
Product
CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Reason for recall
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1635-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.