Z-0275-2008

Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw...

Name: Z-0275-2008 Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw...
Creator: Zimmer Inc.
Published: 2007-09-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-09-26 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708 on 2007-09-26. The reason FDA records is "Mislabeled as to size; 54mm package contains 46 mm device and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0275-2008
Status: Terminated
Initiated: 2007-09-26
Posted: 2007-11-29
Terminated: 2008-06-04
Recalling firm: Zimmer GmbH
Product: Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.
Product code: KXA Prosthesis, Hip, Femoral, Resurfacing
Reason for recall: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.
Quantity in commerce: 1
Distribution: Nationwide
Product codes and lots: Lot 2376766.

Product code KXA

K070292Class IIDurom Hip Resurfacing System, Femoral ComponentsZimmer GmbH / cleared 2007-04-26

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)