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.
This recall has been terminated (originally issued February 7, 2013).
- Company
- Medacta Usa Inc
- Recall Initiated
- December 17, 2012
- Posted
- February 7, 2013
- Terminated
- February 7, 2013
- Recall Number
- Z-0791-2013
- Quantity
- 26 pieces U.S.A. (226 pieces Worldwide)
- Firm Location
- Camarillo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Distribution
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Lot / Code Info
Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
Root Cause
Device Design
Action Taken
Medacta sent a Urgent Safety Notification letter dated December 13, 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to check inventory for affected product and contact QA@medacta.us.com for an RMA# to return items to Medacta USA. A new version of the recalled product will be provided to all affected customers. For questions call 805-437-7085 x26.