FDAFDA · Food and drugs·Recall number Z-0267-2013
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.
Published November 14, 2012 · Recall initiated: October 13, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medacta Usa Inc
- Distributor
- Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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