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U.S. Department of Health and Human Services

Class 2 Device Recall METRx II Tube

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  Class 2 Device Recall METRx II Tube see related information
Date Initiated by Firm January 25, 2006
Date Posted April 12, 2006
Recall Status1 Terminated 3 on July 05, 2007
Recall Number Z-0737-06
Recall Event ID 34653
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product METRx II Tube, 18mm x 7cm stainless steel tubular retractor, Part No. 9569684
Code Information Lot No. FA05K021
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
For Additional Information Contact Bert Kelly
901-396-3133
Manufacturer Reason
for Recall		 Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.
FDA Determined
Cause 2		 Other
Action The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
Quantity in Commerce 4
Distribution IL, IN, MI, CA, Japan, Netherlands
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.
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