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U.S. Department of Health and Human Services

Class 2 Device Recall Drill Sleeve Guide

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 Class 2 Device Recall Drill Sleeve Guidesee related information
Date Initiated by FirmMay 02, 2018
Create DateJuly 25, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall NumberZ-2539-2018
Recall Event ID 80280
510(K)NumberK170442 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductAD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.
Code Information Catalog Number DSG-6.3-090-2.4N. Batch Number (Lot Number): 107104 (710220), 114390 (715001), 111423 (716180), 105176 (613121), 113775 (719190), 115847 (712211), 113776 (719190), 115000 (714201), 114724 (711101), 116389 (712121), 117146 (810110). 
Recalling Firm/
Manufacturer		 Ad-Tech Medical Instrument Corporation
400 W Oakview Pkwy
Oak Creek WI 53154-7213
For Additional Information Contact
262-634-1555 Ext. 3010
Manufacturer Reason
for Recall		The 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		Nonconforming Material/Component
ActionCustomers were notified on 05/02/2018 via a MEDICAL DEVICE RECALL letter. Instructions included to immediately examine your inventory and quarantine any product subject to recall and replacement. Customers/distributors who received affected devices will be contacted to return their unopened/unused and/or reused stock of the affected product.
Quantity in Commerce65 Total
DistributionUS Nationwide distribution in the states of CA, FL, IL, MI, NH, NY, OH, OR, PA, SC, UT, WV. Worldwide distribution to Canada, Denmark, Germany, India, Israel, Japan, Russia, South Korea, Taiwan, United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HBE
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