Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
This recall has been terminated (originally issued November 8, 2012).
- Company
- Medacta Usa Inc
- Recall Initiated
- October 13, 2008
- Posted
- November 8, 2012
- Terminated
- November 9, 2012
- Recall Number
- Z-0267-2013
- Quantity
- 12 units
- Firm Location
- Camarillo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Distribution
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Lot / Code Info
Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)
Root Cause
Nonconforming Material/Component
Action Taken
Medacta USA, sent a Urgent Safety Notification letter dated October 13, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter informed the customers of the lot numbers on recall and the reference numbers. The recall was initiated because the offset broach handles contain a lever mechanism that is connected to the locking axis by means of a metallic wire. The rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. For further questions please call (858) 705-0350.