Dual-Sided Interhemispheric recall
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Why was Dual-Sided Interhemispheric 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All catalog numbers and lot numbers distributed through May 30, 2019
- Product
- Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Quantity
- 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.
- Recall date
- September 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)