FDAClass IIMay 11, 2016

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA recall: Labeling Error

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Why was Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA recalled?

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Catalog Number: 10BA40D, Lot Number: H5237248

Product
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Recalling firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Quantity
81 tools
Distribution
Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls