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.
Reported: February 13, 2013 Initiated: December 17, 2012 #Z-0791-2013
Product Description
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.
Reason for Recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Details
- Recalling Firm
- Medacta Usa Inc
- Units Affected
- 26 pieces U.S.A. (226 pieces Worldwide)
- Distribution
- US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medacta Usa Inc. Units affected: 26 pieces U.S.A. (226 pieces Worldwide).
Why was this product recalled? ▼
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2013. Severity: Moderate. Recall number: Z-0791-2013.
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