Z-0330-06

Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482

Name: Z-0330-06 Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482
Creator: Medtronic Sofamor Danek Instrument Manufacturing
Published: 2005-11-28
License: https://open.fda.gov/license/

Medtronic Sofamor Danek Instrument Manufacturing / initiated 2005-11-28 / Terminated

FDA source

Medtronic Sofamor Danek Instrument Manufacturing began a recall of Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482 on 2005-11-28. The reason FDA records is "Screwdriver handle breakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0330-06
Status: Terminated
Initiated: 2005-11-28
Posted: 2005-12-28
Terminated: 2006-11-09
Recalling firm: Medtronic Sofamor Danek Instrument Manufacturing
Product: Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482
Product code: HXX Screwdriver
Reason for recall: Screwdriver handle breakage
FDA root cause: Other
Action: The recalling firm sent out a letter dated 12/01/2005 explaining the problem and requesting return of the product.
Quantity in commerce: 75 units
Distribution: IL, IN, MI, CA, Japan, Netherlands
Product codes and lots: Lot numbers: M05J0371, M05E0548

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)