Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Reported: September 4, 2019 Initiated: June 18, 2019 #Z-2406-2019
Product Description
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Reason for Recall
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.
Details
- Recalling Firm
- Ad-Tech Medical Instrument Corporation
- Units Affected
- 187,666 devices with possible affected supplemetal information
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide distribution to Albania, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam.
- Location
- Oak Creek, WI
Frequently Asked Questions
What product was recalled? ▼
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes. Recalled by Ad-Tech Medical Instrument Corporation. Units affected: 187,666 devices with possible affected supplemetal information.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2019. Severity: Moderate. Recall number: Z-2406-2019.
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