12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14… — Class II medical device recall Z-2427-2012
Terminated recall by Smith & Nephew Inc, reported 2012-09-26, distributed nationwide. Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
| Recall number | Z-2427-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2012-08-22 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-02-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 70 units |
| Reason classes | specification failure |
| Lot numbers | 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A, 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, 12FTM0021C |
| Model numbers | 71352112 |
Product
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Reason for recall
Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
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-2427-2012. 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.