Class 2 Device Recall Gladiator Bipolar

• Date Initiated by Firm: January 03, 2007
• Date Posted: March 07, 2007
• Recall Status: Terminated on January 15, 2009
• Recall Number: Z-0568-2007
• Recall Event ID: 37250
• 510(K)Number: K062693
• Product Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented - Product Code KWY
• Product: Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head
• Code Information: Lot Nos.: 106381250, 106382088, 116389380 (3 were implanted)
• Recalling Firm/ Manufacturer: Wright Medical Technology Inc; 5677 Airline Road; PO Box 100; Arlington TN 38002-0100
• For Additional Information Contact: Debbie Daurer; 901-867-4601
• Manufacturer Reason for Recall: Product specification failure which could result in improper locking of the cup onto the femoral head.
• FDA Determined 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: 17 units
• Distribution: Nationwide and Japan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWY