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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 Tubesee related information
Date Initiated by FirmJanuary 25, 2006
Date PostedApril 12, 2006
Recall Status1 Terminated 3 on July 05, 2007
Recall NumberZ-0730-06
Recall Event ID 34653
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
ProductMETRx II Tube, 16mm x 7cm stainless steel tubular retractor, Part No. 9569674
Code Information Lot No. FA05K014
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
For Additional Information ContactBert 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
ActionThe firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
Quantity in Commerce1
DistributionIL, IN, MI, CA, Japan, Netherlands
Total Product Life CycleTPLC 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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