Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head
This recall has been terminated (originally issued March 7, 2007).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- January 3, 2007
- Posted
- March 7, 2007
- Terminated
- January 15, 2009
- Recall Number
- Z-0572-2007
- Quantity
- 14 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Product specification failure which could result in improper locking of the cup onto the femoral head.
Distribution
Nationwide and Japan
Lot / Code Info
Lot Nos.: 106381256, 106382092
Root Cause
Other
Action Taken
The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.
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