Recall Z-0568-2007 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Wright Medical Technology Inc
Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head
| Date | Mar 7, 2007 (initiated Jan 3, 2007) |
| Status | Terminated |
| Reason | Product specification failure which could result in improper locking of the cup onto the femoral head. |
| Root cause | Other |
| Action | 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. |
| Quantity | 17 units |
| Distribution | Nationwide and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062693 | GLADIATOR BIPOLAR SYSTEM Wrightmedicaltechnologyinc, Sep 29, 2006 |