Zimmer, Inc.: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus A

Zimmer, Inc.: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software

Medical DevicesSource: FDA (device) · Date: 2025-12-31

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Zimmer, Inc.
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 / 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.
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Recall initiated: 2025-12-02
Code info: 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
Product quantity: 24
Voluntary mandated: Voluntary: Firm initiated
City: Warsaw
State: IN
Country: United States
Event id: 98069