Brand Name: Affixus Antegrade Femoral Nailing System Product Name:… — Class II medical device recall Z-0967-2026
Ongoing recall by Zimmer, Inc., reported 2025-12-31, distributed nationwide. Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant f
| Recall number | Z-0967-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2025-12-02 |
| Classified | 2025-12-22 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 22 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00887868143526 |
| Lot numbers | 66717551, 66884561 |
| Model numbers | 815509320 |
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Reason for recall
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
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-0967-2026. 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.