Z-0539-05

MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer...

Name: Z-0539-05 MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer...
Creator: Zimmer Austin, Inc
Published: 2004-12-17
License: https://open.fda.gov/license/

Centerpulse Orthopedics, Inc. / initiated 2004-12-17 / Terminated

FDA source

Zimmer Austin, Inc began a recall of MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717 on 2004-12-17. The reason FDA records is "Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0539-05
Status: Terminated
Initiated: 2004-12-17
Posted: 2005-02-15
Terminated: 2007-11-27
Recalling firm: Centerpulse Orthopedics, Inc.
Product: MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
FDA root cause: Other
Action: The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.
Quantity in commerce: 121 units
Distribution: The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal
Product codes and lots: Catalog Numbers: 5000-50-100 and 5000-50-200; Lot Numbers: 1529444, 1536181, 1538936, 1538937, 1542189, 1568350, 1568351, 1569597, 1596886, 1596890, 1601839, 1601841, 1610470, 1616609, and 1617691

Product code KRO

K013031Class IIMost Options SystemSulzer Orthopedics, Inc. / cleared 2001-12-07

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)