FDA Device recall Z-0975-2026
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 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: 815609320 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-0975-2026 |
| 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: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, 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 815609320 ; UDI-DI (01)00887868144479(17)340826(10)66717601 ; Lot Number 66717601 Model No 815609320…Lot Code: Model No 815609320 ; UDI-DI (01)00887868144479(17)340826(10)66717601 ; Lot Number 66717601 Model No 815609320 ; UDI-DI (01)00887868144479(17)340820(10)66892900 ; Lot Number 66892900 |
|---|
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-0975-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.