Z-0460-03

Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14...

Name: Z-0460-03 Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14...
Creator: Zimmer Inc.
Published: 2003-01-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2003-01-06 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03 on 2003-01-06. The reason FDA records is "Compression test results are not in accordance with device approval submission". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0460-03
Status: Terminated
Initiated: 2003-01-06
Posted: 2003-01-23
Terminated: 2003-12-04
Recalling firm: Zimmer GmbH
Product: Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Compression test results are not in accordance with device approval submission
FDA root cause: Other
Action: Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
Distribution: United States.
Product codes and lots: all lots.

Product code LZO

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)