medical Class II Updated 2019-09-04

Ad-Tech Medical Instrument Corporation recalls Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wy

Recalled Product

Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes

Hazard / Issue

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All catalog numbers and lot numbers distributed through May 30, 2019
View official government recall

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