Recall Z-0570-2007
Wright Medical Technology Inc · initiated January 3, 2007
Product
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head
Codes / lots: Lot Nos.: 106381253, 106382090
Reason for recall
Product specification failure which could result in improper locking of the cup onto the femoral head.
FDA-determined 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.
Details
- Recall number
- Z-0570-2007
- Initiated
- January 3, 2007
- Posted by FDA
- March 7, 2007
- Terminated
- January 15, 2009
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Quantity
- 12 units
- Distribution
- Nationwide and Japan
- Recalling firm
- Wright Medical Technology Inc, Arlington, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0567-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0568-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0569-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0571-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0572-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0573-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |