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Class 2 Device Recall ADTECH Drill Sleeve Guides |
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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
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Product Classification |
Drills, burrs, trephines & accessories (manual) - Product Code HBG
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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
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For Additional Information Contact |
262-634-1555
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HBG and Original Applicant = Ad-Tech Medical Instrument Corporation
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