BIORAPTOR Suture Anchors — Class II medical device recall Z-0581-2025
Ongoing recall by Smith & Nephew Inc., reported 2024-12-11, distributed nationwide. Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
| Recall number | Z-0581-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc., Andover, MA, United States |
| Recall initiated | 2024-10-29 |
| Classified | 2024-11-29 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 2,156 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 03596010595072, 03596010595089, 03596010656452, 03596010656469 |
| Lot numbers | 2146369, 2151242, 2151690, 2151692, 2153489, 2154691 |
| Model numbers | 72201541, 72201542, 72203280, 72203281 |
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Reason for recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
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-0581-2025. 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.