Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head
FDA Recall Z-0571-2007 · Posted 2007-03-07
Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeKWY
Date Initiated2007-01-03
Date Terminated2009-01-15
Product Quantity13 units
Reason for Recall
Product specification failure which could result in improper locking of the cup onto the femoral head.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.