Recall Z-0267-2013 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Medacta Usa Inc
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.
| Date | Nov 8, 2012 (initiated Oct 13, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 12 units |
| Distribution | Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.