FDA Device recall Z-0970-2026
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software…
- FDA Device
- Class II
- ongoing
- Published 2025-12-31
On 2025-12-31 the FDA classified a Class II recall of Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software… by Zimmer, citing 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 oc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0970-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-02 |
| Published | 2025-12-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zimmer |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Lot Code: Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66717554 ; Lot Number 66717554 Model No 815509380…Lot Code: Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66717554 ; Lot Number 66717554 Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66884564 ; Lot Number 66884564 Model No 815509380 ; UDI-DI (01)00887868143557(17)350421(10)67042197 ; Lot Number 67042197 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0970-2026%22
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