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U.S. Department of Health and Human Services

Class 3 Device Recall screw driver

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  Class 3 Device Recall screw driver see related information
Date Initiated by Firm November 28, 2005
Date Posted December 28, 2005
Recall Status1 Terminated 3 on November 09, 2006
Recall Number Z-0330-06
Recall Event ID 34196
Product Classification Screwdriver - Product Code HXX
Product Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482
Code Information Lot numbers: M05J0371, M05E0548
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
For Additional Information Contact Jill Serbousek
800-876-3133
Manufacturer Reason
for Recall		 Screwdriver handle breakage
FDA Determined
Cause 2		 Other
Action The recalling firm sent out a letter dated 12/01/2005 explaining the problem and requesting return of the product.
Quantity in Commerce 75 units
Distribution IL, IN, MI, CA, Japan, Netherlands
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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