FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek Instrument Manufacturing: Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
- Recall number
- Z-0050-2007
- Recalling firm
- Medtronic Sofamor Danek Instrument Manufacturing
- Product
- Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
- Status
- Terminated
- Initiated
- 2006-08-01
- Posted
- 2006-10-19
- Terminated
- 2007-04-04
- Reason
- Bone reamer may not have a cutting surface on the tip.
- Root cause
- Other
- Action
- The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.
- Quantity
- 9 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Nos.: CN04J012, CN06A003
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- Firm FEI
- 3004564008
- Firm city
- Bartlett
- 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