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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Midas Rex Dissecting Tool Legend

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 Class 2 Device Recall Medtronic Midas Rex Dissecting Tool Legendsee related information
Date Initiated by FirmApril 08, 2016
Date PostedMay 04, 2016
Recall Status1 Terminated 3 on February 16, 2017
Recall NumberZ-1602-2016
Recall Event ID 73869
510(K)NumberK020069 
Product Classification Motor, drill, pneumatic - Product Code HBB
ProductMedtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Code Information Product Catalog Number: 10BA40D, Lot Number: H5237248
Recalling Firm/
Manufacturer
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
4620 N Beach St
Haltom City TX 76137-3219
For Additional Information ContactDavid Leers
817-788-6587
Manufacturer Reason
for Recall
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
FDA Determined
Cause 2
Labeling mix-ups
ActionA notification letter was provided to each consignee, translated as necessary, on April 8, 2016.
Quantity in Commerce81 tools
DistributionDistributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
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.
510(K) Database510(K)s with Product Code = HBB
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