Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
FDA Recall Z-0176-2007 · Posted 2006-11-14
Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeLYS
Date Initiated2006-10-20
Date Terminated2007-04-04
Product Quantity255 units
Reason for Recall
Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
Firm Action
The 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.