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Terminated

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

FDA Recall Z-0569-2007 · Posted 2007-03-07

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeKWY
Date Initiated2007-01-03
Date Terminated2009-01-15
Product Quantity12 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.

K062693GLADIATOR BIPOLAR SYSTEMWrightmedicaltechnologyinc · 2006-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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