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.
Reported: November 14, 2012 Initiated: October 13, 2008 #Z-0267-2013
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.
Details
- Recalling Firm
- Medacta Usa Inc
- Units Affected
- 12 units
- Distribution
- Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medacta Usa Inc. Units affected: 12 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0267-2013.
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