Recall Z-0176-2007 ยท LYS Bone Mill
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
| Date | Nov 14, 2006 (initiated Oct 20, 2006) |
| Status | Terminated |
| Reason | Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use. |
| Root cause | Other |
| 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. |
| Quantity | 255 units |
| Distribution | Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.