Z-0050-2007

Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA...

Name: Z-0050-2007 Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA...
Creator: Medtronic Sofamor Danek Instrument Manufacturing
Published: 2006-08-01
License: https://open.fda.gov/license/

Medtronic Sofamor Danek Instrument Manufacturing / initiated 2006-08-01 / Terminated

FDA source

Medtronic Sofamor Danek Instrument Manufacturing began a recall of 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... on 2006-08-01. The reason FDA records is "Bone reamer may not have a cutting surface on the tip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0050-2007
Status: Terminated
Initiated: 2006-08-01
Posted: 2006-10-19
Terminated: 2007-04-04
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).
Product code: HTO Reamer
Reason for recall: Bone reamer may not have a cutting surface on the tip.
FDA 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 in commerce: 9 units
Distribution: Nationwide
Product codes and lots: Lot Nos.: CN04J012, CN06A003

Product code HTO

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)