FDA Device recall Z-0978-2026
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 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: 815609380 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-0978-2026 |
| 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: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 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 815609380 ; UDI-DI (01)00887868144509(17)340826(10)66717604 ; Lot Number 66717604 Model No 815609380…Lot Code: Model No 815609380 ; UDI-DI (01)00887868144509(17)340826(10)66717604 ; Lot Number 66717604 Model No 815609380 ; UDI-DI (01)00887868144509(17)340820(10)66892903 ; Lot Number 66892903 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-07-01 · Zimmer - Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
FDA Device · Class II · 2026-07-01 · Zimmer - Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10…
FDA Device · Class II · 2026-07-01 · Zimmer - Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
FDA Device · Class II · 2026-07-01 · Zimmer
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0978-2026%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.