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U.S. Department of Health and Human Services

Class 2 Device Recall ADTECH Drill Sleeve Guides

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  Class 2 Device Recall ADTECH Drill Sleeve Guides see related information
Date Initiated by Firm August 27, 2019
Create Date September 13, 2019
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Ad-Tech Medical Instrument Corporation
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