Stryker CinchLock Flex Knotless Anchor with Inserter and Suture — Class II medical device recall Z-1328-2025
Ongoing recall by Stryker Corporation, reported 2025-03-19, distributed nationwide. Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the
| Recall number | Z-1328-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2025-01-29 |
| Classified | 2025-03-12 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CO, ES, GB, MX, NL |
| Quantity | 9,521 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07613327123661 |
| Lot numbers | 23342AE2, 23345AE2, 24004AE2, 24008AE2, 24009AE2, 24010AE2, 24032AE2, 24033AE2, 24036AE2, 24050AE2, 24061AE2, 24064AE2, 24065AE2, 24066AE2, 24087AE2, 24093AE2, 24094AE2, 24127AE2, 24128AE2, 24135AE2, 24136AE2, 24137AE2, 24143AE2, 24144AE2, 24159AE2, 24160AE2, 24162AE2, 24169AE2, 24170AE2, 24184AE2, 24185AE2, 24186AE2, 24190AE2, 24200AE2, 24201AE2, 24204AE2, 24205AE2, 24206AE2, 24214AE2, 24215AE2 and 24 more |
| Model numbers | 02643 |
Product
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Reason for recall
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
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-1328-2025. 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.