Affixus Hip Fracture Nail Left 130 Deg 11x300mm — Class II medical device recall Z-0449-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-11-21, distributed nationwide. The set screw is not able to advance or reverse from the original position in the nail.
| Recall number | Z-0449-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-10-02 |
| Classified | 2018-11-13 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CR, EC, NL |
| Quantity | 2,163 in |
| Lot numbers | 157410, 171840 |
| Model numbers | 814611300 |
Product
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Reason for recall
The set screw is not able to advance or reverse from the original position in the 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-0449-2019. 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.