Z-0211-04

C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm

Name: Z-0211-04 C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm
Creator: Interpore Cross International Inc
Published: 2003-11-07
License: https://open.fda.gov/license/

Interpore Cross International Inc / initiated 2003-11-07 / Terminated

FDA source

Interpore Cross International Inc began a recall of C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm on 2003-11-07. The reason FDA records is "Step drills from Lot 25947 may have been mis-etched". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0211-04
Status: Terminated
Initiated: 2003-11-07
Posted: 2003-12-11
Terminated: 2004-04-20
Recalling firm: Interpore Cross International Inc
Product: C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm
Product code: DKA Antiserum, Digoxin
Reason for recall: Step drills from Lot 25947 may have been mis-etched.
FDA root cause: Other
Action: The consignees will be notified by letter.
Quantity in commerce: 433 units
Distribution: U.S., Netherlands, Australia, Venezuela, Mexico, Columbia and Brazil
Product codes and lots: Lot #25947 Catalog # 1100-9019 & #1100-9020

Product code DKA

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)