Reported Feb 13, 2013 · Terminated
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product…
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 Ste B · Camarillo, CA · 93012-8429
Is this the product you have?
- Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
- Lot codes and dates
- Lot/Unit Codes
075023075064084000084001084326084743084815085202085455
- Lot/Unit Codes
- Amount recalled
- 26 pieces U.S.A. (226 pieces Worldwide)
Where it was sold
Why it was recalled
The tip of the Quadra Trial Broach size 0, broke during a surgery.
This product could cause temporary or reversible health problems — stop using it.
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