FDA-Device2012-11-14Class II
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.
Medacta Usa Inc
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.
Sold states
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Affected count
12 units
Manufactured in
4725 Calle Quetzal Unit B, N/A, Camarillo, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2013Don't want to check this manually?
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