Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 02, 2025 |
| Reported | December 31, 2025 |
| Recalling firm | Zimmer, Inc. |
| Country / region | United States IN |
Hazard
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.
Affected products
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product
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