FDA · Medical device recall

Dual-Sided Interhemispheric… and 2 more products

Sept. 4, 2019 Class II

Date: Sept. 4, 2019
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Ad-Tech Medical Instrument Corporation
Distribution pattern: 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.

3 products in this recall

Dual-Sided Interhemispheric…

Product: Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Reason: 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.
Quantity: 187,666 devices with possible affected supplemetal information
Codes and lots: All catalog numbers and lot numbers distributed through May 30, 2019
Recall started: June 18, 2019
Device type: Electrode, Cortical
Root cause (FDA): Employee error
What the company told customers: Ad-Tech Medical Instrument Corporation notified customers on about 06/18/2019, via "MEDICAL DEVICE RECALL" letter. The letter notified customers that the recall included supplemental information and not the actual physical device. Supplemental information includes: 1. Catalog - MKTG-3006 Product Catalog; 2. Attachment/Files: - Subdural MRI Certification, - Subdural MRI Testing Scheinder, - Subdural RF Heating Kanal, - Depth Electrode MRI Certification, - Depth MRI Testing Scheinder, - Depth RF Heating Kanal; 3. Journal Articles: Carmichael_NI_2010 - Feasibility of simultaneous intracranial EEG-fMRI in humans: A safety study, Carmichael_NI_2012 Simultaneous EEG-fMRI in humans: Protocol considerations and data quality, Vulliemoz_NI_2011 Simultaneous intracranial EEG and fMRI of interictal epileptic discharges in humans. Actions to be taken by the customer included to immediately examine records for any documentation subject to the recall for affected devices, and if any of the affected documentation has been further distributed, to identify those customers/personnel and immediately notify them of the recall. A copy of the recall notification letter can be included in that notification. Customers were also requested to complete the provided response form to acknowledge understanding that the devices are not approved for use as described in the recalled supplemental information. The response form also requested that customers acknowledge that the supplemental information has been properly destroyed and/or dispose of. The response form should be returned to the Ad-Tech Regulatory Team at FAX: 262-634-5668, Telephone: 262-634-1555, Email: Regulatory@adtechmedical.com. Questions or issues can also be directed to this team at the above contacts Monday - Friday 7:00 AM to 5:00 PM, Central Time.
Recall number: Z-2406-2019

Depth Electrodes…

Product: Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
Reason: 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.
Quantity: 107,757 devices with possible affected supplemetal information
Codes and lots: All catalog numbers and lot numbers distributed through May 30, 2019
Recall started: June 18, 2019
Device type: Electrode, Depth
Root cause (FDA): Employee error
What the company told customers: Ad-Tech Medical Instrument Corporation notified customers on about 06/18/2019, via "MEDICAL DEVICE RECALL" letter. The letter notified customers that the recall included supplemental information and not the actual physical device. Supplemental information includes: 1. Catalog - MKTG-3006 Product Catalog; 2. Attachment/Files: - Subdural MRI Certification, - Subdural MRI Testing Scheinder, - Subdural RF Heating Kanal, - Depth Electrode MRI Certification, - Depth MRI Testing Scheinder, - Depth RF Heating Kanal; 3. Journal Articles: Carmichael_NI_2010 - Feasibility of simultaneous intracranial EEG-fMRI in humans: A safety study, Carmichael_NI_2012 Simultaneous EEG-fMRI in humans: Protocol considerations and data quality, Vulliemoz_NI_2011 Simultaneous intracranial EEG and fMRI of interictal epileptic discharges in humans. Actions to be taken by the customer included to immediately examine records for any documentation subject to the recall for affected devices, and if any of the affected documentation has been further distributed, to identify those customers/personnel and immediately notify them of the recall. A copy of the recall notification letter can be included in that notification. Customers were also requested to complete the provided response form to acknowledge understanding that the devices are not approved for use as described in the recalled supplemental information. The response form also requested that customers acknowledge that the supplemental information has been properly destroyed and/or dispose of. The response form should be returned to the Ad-Tech Regulatory Team at FAX: 262-634-5668, Telephone: 262-634-1555, Email: Regulatory@adtechmedical.com. Questions or issues can also be directed to this team at the above contacts Monday - Friday 7:00 AM to 5:00 PM, Central Time.
Recall number: Z-2407-2019

Skull Anchor Bolts

Product: Skull Anchor Bolts
Reason: Supplemental information provided with devices may indicate 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.
Quantity: 22,810 devices with possible affected supplemetal information
Codes and lots: All catalog numbers and lot numbers distributed through May 30, 2019
Recall started: June 18, 2019
Device type: Electrode, Depth
Root cause (FDA): Employee error
What the company told customers: Ad-Tech Medical Instrument Corporation notified customers on about 06/18/2019, via "MEDICAL DEVICE RECALL" letter. The letter notified customers that the recall included supplemental information and not the actual physical device. Supplemental information includes: 1. Catalog - MKTG-3006 Product Catalog; 2. Attachment/Files: - Subdural MRI Certification, - Subdural MRI Testing Scheinder, - Subdural RF Heating Kanal, - Depth Electrode MRI Certification, - Depth MRI Testing Scheinder, - Depth RF Heating Kanal; 3. Journal Articles: Carmichael_NI_2010 - Feasibility of simultaneous intracranial EEG-fMRI in humans: A safety study, Carmichael_NI_2012 Simultaneous EEG-fMRI in humans: Protocol considerations and data quality, Vulliemoz_NI_2011 Simultaneous intracranial EEG and fMRI of interictal epileptic discharges in humans. Actions to be taken by the customer included to immediately examine records for any documentation subject to the recall for affected devices, and if any of the affected documentation has been further distributed, to identify those customers/personnel and immediately notify them of the recall. A copy of the recall notification letter can be included in that notification. Customers were also requested to complete the provided response form to acknowledge understanding that the devices are not approved for use as described in the recalled supplemental information. The response form also requested that customers acknowledge that the supplemental information has been properly destroyed and/or dispose of. The response form should be returned to the Ad-Tech Regulatory Team at FAX: 262-634-5668, Telephone: 262-634-1555, Email: Regulatory@adtechmedical.com. Questions or issues can also be directed to this team at the above contacts Monday - Friday 7:00 AM to 5:00 PM, Central Time.
Recall number: Z-2408-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2406-2019, Z-2407-2019, Z-2408-2019. The agency record governs; check it and the company before acting.

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