FDAFDA · Food and drugs·Recall number Z-0791-2013
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.
Published February 13, 2013 · Recall initiated: December 17, 2012
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
The tip of the Quadra Trial Broach size 0, broke during a surgery.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Medacta Usa Inc
- Distributor
- US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
- Lot
- Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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