Z-2343-2012 Class II Terminated
Recalled by Medtronic Xomed, Inc.
— Jacksonville, FL
FDA device recall Z-2343-2012 was initiated by Medtronic Xomed, Inc. on Sep 27, 2010 and is designated Class II. Reason for recall: In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0… The recall status is terminated (terminated Nov 26, 2013). Affected quantity: 53.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2012
- Initiation Date
- Sep 27, 2010
- Termination Date
- Nov 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53
Product Description
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
Reason for Recall
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
Code Information
8253410 (Neuro). All Serial Numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2343-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.