Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
FDA device recall Z-0176-2007 · posted 2006-11-14 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
- Action taken
- 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
- Status
- Terminated
- Product code
- LYS
- Quantity affected
- 255 units
- Distribution
- Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.
- Date initiated
- 2006-10-20
- Date posted
- 2006-11-14
- Date terminated
- 2007-04-04
- Location
- Memphis, TN
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