Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 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.