FDA-Device2013-02-13Class II
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.
Medacta Usa Inc
Hazard
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Sold states
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Affected count
26 pieces U.S.A. (226 pieces Worldwide)
Manufactured in
4725 Calle Quetzal Ste B, N/A, Camarillo, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0791-2013Don't want to check this manually?
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