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U.S. Department of Health and Human Services

Class 2 Device Recall Metrx

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  Class 2 Device Recall Metrx see related information
Date Initiated by Firm June 20, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on February 08, 2006
Recall Number Z-0993-05
Recall Event ID 32511
510(K)Number K993021  
Product Classification arthroscopy - Product Code HRX
Product Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
Code Information All lots.
Recalling Firm/
Warsaw Orthopedic, Inc.
2500 Silveus Xing
Warsaw IN 46582-8598
For Additional Information Contact
800-876-3133 Ext. 4668
Manufacturer Reason
for Recall
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
FDA Determined
Cause 2
Package design/selection
Action Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
Distribution Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
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 = HRX and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.