Z-2204-2019Class II

LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap...

Name: Z-2204-2019 LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap...
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 LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm... on 2019-06-18. FDA classified it as Class II and gives the reason as "On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one...". 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-2204-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Posted: 2019-08-06
Terminated: 2021-02-16
Recalling firm: AD-Tech Medical Instrument Corp.
Product: LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.
Product code: GZL Electrode, Depth
Reason for recall: On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Ad-Tech Medical notified customers on about 06/18/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were instructed to immediately examine inventory and quarantine any parts subject to the recall, notify all customers if the affected parts have been further distributed, and provide a copy of the recall notification letter. Additionally, customers were instructed to complete and return the customer response form, contact Ad-Tech Customer Support Specialists to obtain a Return Material Authorization (RMA) number, and return all affected parts to Ad-Tech Medical Instrument Corporation at 400 West Oakview Parkway, Oak Creek, WI 53154. The customer response form should be sent to the Ad-Tech Regulatory Team at FAX: 262-634-5668, Telephone: 262-634-1555, Email: [email protected]. Questions and concerns can also be directed to the Ad-Tech Regulatory Team at the above contact information Monday through Friday, 7:00 AM to 5:00 PM, Central Time.
Quantity in commerce: 201 devices
Distribution: Worldwide distribution - US Nationwide distribution in the state of Georgia and country of Australia.
Product codes and lots: All codes shipped between March 1, 2019 and May 31, 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2204-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2204-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

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)