979195 Loaner Kit for femoral intramedullary nail — Class II medical device recall Z-0775-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-07, distributed nationwide. Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral
| Recall number | Z-0775-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-09-13 |
| Classified | 2018-02-27 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 337 total |
| Reason classes | device malfunction |
Product
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Reason for recall
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
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-0775-2018. 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.