Class 2 Device Recall LSB Style Anchor Bolt

• Date Initiated by Firm: June 18, 2019
• Create Date: August 06, 2019
• Recall Status: Terminated on February 16, 2021
• Recall Number: Z-2204-2019
• Recall Event ID: 83246
• 510(K)Number: K181544
• Product Classification: Electrode, depth - Product Code GZL
• 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.
• Code Information: All codes shipped between March 1, 2019 and May 31, 2019.
• Recalling Firm/ Manufacturer: Ad-Tech Medical Instrument Corporation; 400 W Oakview Pkwy; Oak Creek WI 53154-7213
• For Additional Information Contact: Suzie Towers; 262-634-1555 Ext. 3000
• Manufacturer 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.
• FDA Determined 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 in Commerce: 201 devices
• Distribution: Worldwide distribution - US Nationwide distribution in the state of Georgia and country of Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GZL and Original Applicant = Ad-Tech Medical Instrument Corporation