Z-2408-2019Class II

Skull Anchor Bolts

Name: Z-2408-2019 Skull Anchor Bolts
Creator: Ad-Tech Medical Instrument Corporation
Published: 2019-06-18
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2019-06-18 / Terminated / root cause: manufacturing process

FDA source

Ad-Tech Medical Instrument Corporation began a recall of Skull Anchor Bolts on 2019-06-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2408-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Posted: 2019-08-28
Terminated: 2023-01-20
Recalling firm: AD-Tech Medical Instrument Corp.
Product: Skull Anchor Bolts
Product code: GZL Electrode, Depth
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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: [email protected]. 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.
Quantity in commerce: 22,810 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.
Product codes and lots: All catalog numbers and lot numbers distributed through May 30, 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2408-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2406-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2407-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2408-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

Product code GZL

K181544Class IIAnchor Bolt (as an accessory to Depth Electrodes)Ad-Tech Medical Instrument Corporation / cleared 2018-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)