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Medacta Usa Inc recalls Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as th
Recalled November 14, 2012 · FDA recall Z-0267-2013 · Medacta Usa
Hazard
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. · FDA Class II
Units
12 units
Sold at
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Description
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.
Product
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.
Manufacturer(s)
Medacta Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →