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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Distal Femur Axial Pin

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  Class 2 Device Recall Guardian Distal Femur Axial Pin see related information
Date Initiated by Firm January 03, 2006
Date Posted February 16, 2006
Recall Status1 Terminated 3 on January 29, 2007
Recall Number Z-0523-06
Recall Event ID 34526
510(K)Number K013035  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Guardian¿ Distal Femur Axial Pin
Code Information Lot Nos. 75258083 and 7521663501
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Road
P.O. Box 100
Arlington TN 38002-0100
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall		 The product was not fully assembled prior to packaging.
FDA Determined
Cause 2		 Other
Action The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.
Quantity in Commerce 10
Distribution Nationwide and PR
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 = JDI and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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