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: 815809280 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: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis 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 815809280 ; UDI-DI (01)00887868584763(17)350416(10)67066287 ; Lot Number 67066287
Product quantity: 3
Voluntary mandated: Voluntary: Firm initiated
City: Warsaw
State: IN
Country: United States
Event id: 98069