ROTATION MEDICAL TENDON STAPLES — Class II medical device recall Z-3097-2024
Ongoing recall by Smith & Nephew Inc., reported 2024-09-18, distributed nationwide. Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the
| Recall number | Z-3097-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc., Andover, MA, United States |
| Recall initiated | 2024-08-12 |
| Classified | 2024-09-10 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CL, CN, DE, ES, FR, GB, GR, HK, IN, IT, JP, LT, MT, MY, NZ, PL, PT, RO, SG, SI, ZA |
| Quantity | 2,961 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00885556733486 |
| Lot numbers | 51192136, 51192143, 51192144, 51192145, 51192146, 51192148, 51192150, 51192151, 51192152, 51192153, 51192154, 51204480, 51204481, 51204484, 51204485, 51204486, 51204487, 51204488, 51204489, 51204491, 51223193, 51223241, 51223242, 51223243, 51223249, 51224282 |
Product
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Reason for recall
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
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-3097-2024. 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.