Device 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.
Z-0791-2013
Product summary
- Firm
- Medacta Usa Inc
- Event
- Event 64160
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 pieces U.S.A. (226 pieces Worldwide)
- Official record key
device-enforcement:Z-0791-2013
Official wording
Reason: The tip of the Quadra Trial Broach size 0, broke during a surgery.
Code information: Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
Distribution pattern: US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Derived failure modes
-
Unknown
The tip of the Quadra Trial Broach size 0, broke during a surgery.