Z-0569-2007

Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm...

Name: Z-0569-2007 Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm...
Creator: Wright Medical Technology Inc
Published: 2007-01-03
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2007-01-03 / Terminated

FDA source

Wright Medical Technology Inc began a recall of Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head on 2007-01-03. The reason FDA records is "Product specification failure which could result in improper locking of the cup onto the femoral head". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0569-2007
Status: Terminated
Initiated: 2007-01-03
Posted: 2007-03-07
Terminated: 2009-01-15
Recalling firm: Wright Medical Technology Inc
Product: Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: Product specification failure which could result in improper locking of the cup onto the femoral head.
FDA 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 in commerce: 12 units
Distribution: Nationwide and Japan
Product codes and lots: Lot Nos.: 106381252, 106382089, 116389381

Product code KWY

K062693Class IIGladiator Bipolar SystemWrightmedicaltechnologyinc / cleared 2006-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)