SUTUREFIX Ultra Anchor XL with one — Class II medical device recall Z-2045-2014
Terminated recall by Smith & Nephew, Inc. Endoscopy Division, reported 2014-07-23, distributed nationwide. Sterility of device is compromised due to breach in sterile barrier
| Recall number | Z-2045-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc. Endoscopy Division, Andover, MA, United States |
| Recall initiated | 2014-06-02 |
| Classified | 2014-07-14 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2017-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, DE, DK, ES, FR, GB, IT, NL, NO, PT, SE |
| Quantity | 259 units |
| Reason classes | sterility |
| Lot numbers | 50476555, 50481446 |
Product
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Reason for recall
Sterility of device is compromised due to breach in sterile barrier
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-2045-2014. 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.