Recall Z-0267-2013— Medacta Usa Inc
Class II · Terminated
Class II FDA medical device recall by Medacta Usa Inc, initiated 2008-10-13, terminated 2012-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Medacta Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-10-13
- Terminated
- 2012-11-09
- Firm location
- Camarillo, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.