Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches o...
FDA Recall #Z-0267-2013 — Class II — October 13, 2008
Product Description
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Reason for Recall
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Recalling Firm
Medacta Usa Inc — Camarillo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 units
Distribution
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Code Information
Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated