Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935
Products Sold
Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935
Medtronic Sofamor Danek USA Inc is recalling Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111 due to Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026