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U.S. Department of Health and Human Services

Class 2 Device Recall Gladiator Bipolar

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 Class 2 Recall
Gladiator Bipolar
see related information
Date Posted March 07, 2007
Recall Status1 Terminated on January 15, 2009
Recall Number Z-0570-2007
Recall Event ID 37250
Premarket Notification
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, Tennessee 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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWY and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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