PlainRecalls
FDA Devices Moderate Class II Ongoing

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A

Reported: December 31, 2025 Initiated: December 2, 2025 #Z-0980-2026

Product Description

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, 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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
23
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A. Recalled by Zimmer, Inc.. Units affected: 23.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0980-2026.