Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...
FDA Recall #Z-0968-2026 — Class II — December 2, 2025
Product Description
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
Reason for Recall
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.
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Code Information
Lot Code: Model No 815509340 ; UDI-DI (01)00887868143533(17)340822(10)66717552 ; Lot Number 66717552 Model No 815509340 ; UDI-DI (01)00887868143533(17)340826(10)66884562 ; Lot Number 66884562
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated