TRIGEN INTERTAN NAIL: — Class II medical device recall Z-1636-2014
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-1636-2014 |
|---|---|
| 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 | 13KT36106, 13LT36305, 13LT36306, 13LT36308, 13LT363089, 13LT36310, 13LT36311, 13LT36312, 13LT36313, 13LT36547, 13LT36548, 13LT36549, 13LT36596, 13LT36597, 13LT36598, 13LT36599, 13LT36600, 13LT37009, 13LT37010, 13LT37011, 13LT37012, 13LT37058, 13LT37059, 13LT37060, 13LT37061, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37347, 13MT37348, 13MT37349, 13MT37350, 13MT37351, 13MT37665, 13MT37666, 13MT37667, 13MT37668, 13MT37669 and 14 more |
| Model numbers | 11.5MM, 125, 130, 71675201, 71675202, 71675203, 71675204, 71675205, 71675207, 71675208, 71675211 |
Product
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, 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-1636-2014. 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.