Z-0540-06

Holt Probe Round Straight

Name: Z-0540-06 Holt Probe Round Straight
Creator: Medtronic Sofamor Danek Instrument Manufacturing
Published: 2005-12-22
License: https://open.fda.gov/license/

Medtronic Sofamor Danek Instrument Manufacturing / initiated 2005-12-22 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Sofamor Danek Instrument Manufacturing began a recall of Holt Probe Round Straight on 2005-12-22. The reason FDA records is "Depth indicators are incorrectly labeled (etched) on a measurement instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0540-06
Status: Terminated
Initiated: 2005-12-22
Posted: 2006-02-23
Terminated: 2007-04-06
Recalling firm: Medtronic Sofamor Danek Instrument Manufacturing
Product: Holt Probe Round Straight
Product code: HXX Screwdriver
Reason for recall: Depth indicators are incorrectly labeled (etched) on a measurement instrument.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm notified its direct consignees of the problem with the product and requested the return of any inventory via letter dated 12/22/05.
Quantity in commerce: 50 units
Distribution: Nationwide, Japan, Hong Kong, Australia, The Netherlands Units - Domestic: 31, International: 19
Product codes and lots: JT05F004

Product code HXX

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)