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Medacta Usa Inc recalls Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Produc
Recalled February 13, 2013 · FDA recall Z-0791-2013 · Medacta Usa
Hazard
The tip of the Quadra Trial Broach size 0, broke during a surgery. · FDA Class II
Units
26 pieces U.S.A. (226 pieces Worldwide)
Sold at
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Description
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Product
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Manufacturer(s)
Medacta Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →