Smith & Nephew 5 — Class II medical device recall Z-2167-2012
Terminated recall by Smith & Nephew, Inc. Endoscopy Division, reported 2012-08-15, distributed nationwide. Distal part of the anchor may break on insertion into bone during surgery
| Recall number | Z-2167-2012 |
|---|---|
| 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 | 2012-07-03 |
| Classified | 2012-08-09 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2016-04-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CO, DE, DK, ES, FI, FR, GB, GR, IN, IT, KR, MX, MY, NO, PT, SE, ZA |
| Quantity | 2,204 units |
| Reason classes | device malfunction |
| Lot numbers | 50388182, 50389253, 50391626, 50392272, 50392407, 50395081, 50395680, 50396197, 50400556, 50401558, 50402228, 50403940, 50406036, 50407582, 50409406, 50412647, 50413407, 50414970, 50415864, 50416801, 50418088, 50420654, 50421030, 50421495 |
| Model numbers | 72202896 |
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
Reason for recall
Distal part of the anchor may break on insertion into bone during surgery
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-2167-2012. 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.