Reported Sep 4, 2019 · Terminated
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Ad-Tech Medical Instrument Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ad-Tech Medical Instrument Corporation · 400 W Oakview Pkwy · Oak Creek, WI · 53154-7213
Is this the product you have?
- Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
- Lot codes and dates
- All catalog numbers and lot numbers distributed through May 30, 2019
- Amount recalled
- 187,666 devices with possible affected supplemetal information
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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