Z-2118-2014 Class II Terminated
FDA device recall Z-2118-2014 was initiated by Medtronic Neuromodulation on Jun 11, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jan 22, 2015). Affected quantity: 300 EXPANDED 10/02/2014 130 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 6, 2014
- Initiation Date
- Jun 11, 2014
- Termination Date
- Jan 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 EXPANDED 10/02/2014 130 devices
Product Description
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2118-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026