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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Drill Kit

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  Class 2 Device Recall Disposable Drill Kit see related information
Date Initiated by Firm December 20, 2017
Create Date May 25, 2018
Recall Status1 Terminated 3 on October 12, 2018
Recall Number Z-1938-2018
Recall Event ID 80002
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only.

Used to drill cranial holes using a stereotactic frame.
Code Information Catalog No. DDK2-2.4-30X, Lot No. 0111664 208140649, UDI No. 01008418231011741719080110011174 5208140649;   Catalog No. DDK2-2.8-30X, Lot No. 0111745 208140649, UDI No. 01008418231011671719080110011166 4208140649
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		 There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.
FDA Determined
Cause 2		 Packaging process control
Action The firm, Ad-Tech Medical Instrument Corporation, sent a "MEDICAL DEVICE RECALL" letter on approximately 12/20/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine inventory and quarantine any affected product on hand; notify customers of the recall if affected product was further distributed; complete and return the Acknowledgement and Receipt Form via Fax to: 262-634-5668, Attention Customer Support; Mail to: AD-TECH MEDICAL INSTRUMENT CORPORATION, 1901 WILLIAM STREET, RACINE, WI 53404 or Email to: customersupport@adtechmedical.com, and contact an Ad-Tech Customer Support Specialist for a Return Material Authorization (RMA) number. If you have any further questions, contact Regulatory Team Representative and CAPA/Complaints Manager, Monday through Friday, 7:00 AM to 5:00 PM, Central Time via FAX: 262-634-5668, Toll Free: 1-800-776-1555 or Email: customersupport@adtechmedical.com.
Quantity in Commerce 30 devices
Distribution Worldwide Distribution: US (nationwide) to states of: CA, DC, FL, MI, MA, NC, NY, WA, WI; and country of: Canada. Distributed internationally to the United Kingdom.
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.
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