TRIGEN INTERTAN 1 — Class II medical device recall Z-1637-2014
Terminated recall by Smith & Nephew Inc, reported 2014-05-28. A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
| Recall number | Z-1637-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2014-04-04 |
| Classified | 2014-05-20 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2017-07-01 |
| Countries outside the US | AU, CA, CH, CN, DE, FR, GB, IN, JP, KR, MX, SE, VE, ZA |
| Quantity | 1,253 units |
| Lot numbers | 13KT36282, 13LT36602, 13LT36604, 13LT36605, 13MT37354, 13MT37356, 13MT37358, 13MT37664, 13MT37947, 13MT37949, 14AT38187, 14AT38188, 14AT38705, 14AT38714 |
| Model numbers | 11.5MM, 125, 71676515, 71676556, 71676558, 71676561 |
Product
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
Reason for recall
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
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-1637-2014. 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.