Recalls / —

—#50189

Product

Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head

FDA product code

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K062693

Affected lot / code info

Lot Nos.: 106381250, 106382088, 116389380 (3 were implanted)

Why it was recalled

Product specification failure which could result in improper locking of the cup onto the femoral head.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Wright Medical Technology Inc

Address

5677 Airline Road PO Box 100, Arlington, Tennessee 38002-0100

Distribution

Distribution pattern

Nationwide and Japan

Timeline

Recall initiated

2007-01-03

Posted by FDA

2007-03-07

Terminated

2009-01-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50189. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.