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U.S. Department of Health and Human Services

Class 2 Device Recall Gladiator Bipolar

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  Class 2 Device Recall Gladiator Bipolar see related information
Date Initiated by Firm January 03, 2007
Date Posted March 07, 2007
Recall Status1 Terminated 3 on January 15, 2009
Recall Number Z-0570-2007
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-3652, Size 52mm O.D., use with 36 mm Head
Code Information Lot Nos.: 106381253, 106382090
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 2		 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
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 and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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