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
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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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