Ad-Tech Medical Instrument Corporation: 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.

Recall number

Z-2204-2019

Recalling firm

Ad-Tech Medical Instrument Corporation

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.

Status

Terminated

Initiated

2019-06-18

Posted

not on file

Terminated

2021-02-16

Reason

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

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: Regulatory@adtechmedical.com. 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

201 devices

Distribution

Worldwide distribution - US Nationwide distribution in the state of Georgia and country of Australia.

Lot, serial or model codes

All codes shipped between March 1, 2019 and May 31, 2019.

510(k) numbers

K181544

PMA numbers

not on file

Product code

GZL

Firm FEI

2183456

Firm city

Oak Creek

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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