Z-0176-2007

Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

Name: Z-0176-2007 Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
Creator: Medtronic Sofamor Danek USA Inc
Published: 2006-10-20
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2006-10-20 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111 on 2006-10-20. The reason FDA records is "Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0176-2007
Status: Terminated
Initiated: 2006-10-20
Posted: 2006-11-14
Terminated: 2007-04-04
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
Product code: LYS Bone Mill
Reason for recall: Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
FDA 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 in commerce: 255 units
Distribution: Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.
Product codes and lots: Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935

Product code LYS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)