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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 July 14, 2004
Date Posted August 24, 2004
Recall Status1 Terminated 3 on July 05, 2005
Recall Number Z-1405-04
Recall Event ID 29664
510(K)Number K013035  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Guardian¿ Distal Femur Axial Pin
Code Information Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074 
Recalling Firm/
Wright Medical Technology Inc
5677 Airline Road
P.O. Box 100
Arlington TN 38002-0100
For Additional Information Contact Robert W. Churinetz
Manufacturer Reason
for Recall
Potential for self -locking axial pin to dislodge and 'back out'.
FDA Determined
Cause 2
Action The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
Quantity in Commerce 44
Distribution Nationwide. Ontario, and Taiwan, ROC
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.