Class 2 Device Recall Metrx

• Date Initiated by Firm: June 20, 2005
• Date Posted: July 13, 2005
• Recall Status: Terminated on February 08, 2006
• Recall Number: Z-0992-05
• Recall Event ID: 32511
• 510(K)Number: K993021
• Product Classification: arthroscopy - Product Code HRX
• Product: Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: 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: 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.