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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Sofamor Danek Bone fragmentor

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 Class 2 Device Recall Medtronic Sofamor Danek Bone fragmentorsee related information
Date Initiated by FirmOctober 20, 2006
Date PostedNovember 14, 2006
Recall Status1 Terminated 3 on April 04, 2007
Recall NumberZ-0176-2007
Recall Event ID 36701
Product Classification Bone Fragmentor - Product Code LYS
ProductMedtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
Code Information Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935
FEI Number 1000477302
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132-1719
For Additional Information ContactJill Serbousek
901-399-2912
Manufacturer Reason
for Recall		Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
FDA Determined
Cause 2		Other
ActionThe firm notified its consignees of the problem and the recall by letter delivered via overnight mail on 10/20/2006. The firm''s overseas distributors were also notified via electronic mail on 10/20/2006. The notices requested the discontinuation of use and stated that sales representatives would be retrieving the devices from them.
Quantity in Commerce255 units
DistributionWorldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.
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.
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