WhichRecall
Class IIReported 2025-12-31

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

Recalled by Zimmer, Inc.

Reason for Recall

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture

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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.

Recall Number
Z-0968-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-02
Reported
2025-12-31
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Code Info
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
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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