FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
- Recall number
- Z-0176-2007
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
- Status
- Terminated
- Initiated
- 2006-10-20
- Posted
- 2006-11-14
- Terminated
- 2007-04-04
- 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.
- Lot, serial or model codes
- Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYS
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28