smith&nephew TRIGEN INTERTAN 10S — Class II medical device recall Z-0097-2018
Ongoing recall by Smith & Nephew, Inc., reported 2017-11-22, distributed in CA, CT, IL, MO, TN. A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
| Recall number | Z-0097-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2017-10-24 |
| Classified | 2017-11-16 |
| Reported by FDA | 2017-11-22 |
| Distributed | CA, CT, IL, MO, TN |
| Countries outside the US | DE, IT |
| Quantity | 17 units |
| Lot numbers | 16LM07111 |
| Model numbers | 71675384 |
Product
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Reason for recall
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
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-0097-2018. 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.