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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic ANGLED DRILL

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  Class 2 Device Recall Medtronic ANGLED DRILL see related information
Date Initiated by Firm December 22, 2017
Create Date February 09, 2018
Recall Status1 Terminated 3 on July 31, 2018
Recall Number Z-0566-2018
Recall Event ID 78839
Product Classification Instrument, manual, surgical, general use - Product Code MDM
Product Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Code Information UDI: 00643169363502, Lot Number EM17F015
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information Contact Eric Epperson
901-344-1434
Manufacturer Reason
for Recall		 Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter on 12/22/2017, requesting the return of the product.
Quantity in Commerce 2 units
Distribution MN, NC
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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