Z-0791-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- December 17, 2012
- Termination Date
- February 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 pieces U.S.A. (226 pieces Worldwide)
Product Description
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.
Reason for Recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Distribution Pattern
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Code Information
Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455