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U.S. Department of Health and Human Services

Class 2 Device Recall Midas Rex Legend Dissecting Tool

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  Class 2 Device Recall Midas Rex Legend Dissecting Tool see related information
Date Initiated by Firm October 21, 2015
Create Date November 20, 2015
Recall Status1 Terminated 3 on June 24, 2016
Recall Number Z-0321-2016
Recall Event ID 72541
510(K)Number K020069  
Product Classification Motor, drill, pneumatic - Product Code HBB
Product Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Code Information Catalog Number: 16TA24, Lot Number: 0006936810
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
4620 N Beach St
Haltom City TX 76137-3219
For Additional Information Contact David Leers
817-788-6587
Manufacturer Reason
for Recall		 The wire pass hole is not present on the tools.
FDA Determined
Cause 2		 Process control
Action A recall letter was mailed to consignees on October 21, 2015.
Quantity in Commerce 9 pieces
Distribution Distributed in the states of California, New York, and Texas and the country of Belgium.
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 = HBB and Original Applicant = MEDTRONIC MIDAS REX
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