Class 2 Device Recall ADTECH Drill Sleeve Guides

• Date Initiated by Firm: August 27, 2019
• Create Date: September 13, 2019
• Recall Status: Terminated on April 05, 2023
• Recall Number: Z-2544-2019
• Recall Event ID: 83628
• 510(K)Number: K170442
• Product Classification: Drills, burrs, trephines & accessories (manual) - Product Code HBG
• Product: AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
• Code Information: All serial numbers distributed between January 2014 and May 2019
• Recalling Firm/ Manufacturer: Ad-Tech Medical Instrument Corporation; 400 W Oakview Pkwy; Oak Creek WI 53154-7213
• For Additional Information Contact: 262-634-1555
• Manufacturer Reason for Recall: The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.
• Quantity in Commerce: 315 units
• Distribution: NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France
• 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 = HBG