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U.S. Department of Health and Human Services

Class 2 Device Recall SET SCREW RETAINING DRIVER

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  Class 2 Device Recall SET SCREW RETAINING DRIVER see related information
Date Initiated by Firm January 03, 2014
Date Posted January 30, 2014
Recall Status1 Terminated 3 on May 16, 2014
Recall Number Z-0866-2014
Recall Event ID 67203
Product Classification Screwdriver - Product Code HXX
Product SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc.
Screwdriver - orthopedic manual surgical instrument.
Code Information TI13J01811
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer Reason
for Recall		 The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
FDA Determined
Cause 2		 Reprocessing Controls
Action The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.
Quantity in Commerce 7 units
Distribution US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
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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