FDAClass IIAugust 6, 2014

Medtronic Nexdrive Micropositioning Drive recall

Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the…

Why was Medtronic Nexdrive Micropositioning Drive recalled?

Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.

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?

Lot numbers: 082605614, 082601414, 082602014, 082634313, 082630913, 082629713, 082629613, 082626913, 082623113, 082621413, and 082618213. EXPANDED 10/02/2014 Lot Numbers: 082616214, 082616314, 082618314, and 082618414.

Product
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the…
Recalling firm
Medtronic Neuromodulation
Quantity
300 EXPANDED 10/02/2014 130 devices
Distribution
Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom.
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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