Reported Nov 14, 2012 · Terminated
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the…
Medacta USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medacta Usa Inc · 4725 Calle Quetzal Unit B · Camarillo, CA · 93012-9101
Is this the product you have?
- 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.
- Lot codes and dates
- Ref01.10.10.122 (Lot # 085119)
- Ref01.10.10.123 (Lot # 085120)
- Ref01.10.10.124 (Lot # 085244)
- Ref01.10.10.125 (Lot # 085243)
- Amount recalled
- 12 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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