Z-2418-2008

Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur...

Name: Z-2418-2008 Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur...
Creator: Zimmer Inc.
Published: 2008-07-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-07-22 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of... on 2008-07-22. The reason FDA records is "Instructions for use/surgical technique instructions are inadequate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2418-2008
Status: Terminated
Initiated: 2008-07-22
Posted: 2008-09-26
Terminated: 2009-10-21
Recalling firm: Zimmer GmbH
Product: Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: Instructions for use/surgical technique instructions are inadequate.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: A press release issued on 7/23/08. A letter was sent to implanting surgeons on 7/22/08 advising them of the problem and instructing them to stop implanting these devices until they receive training. Zimmer suspended all marketing and distribution in the U.S. pending completion of user training and revision of the instructions for surgical technique. Zimmer will conduct a removal of all copies of the current surgical technique document and replace it with revised surgical technique document(s). Contact Zimmer, Inc. at 1-866-946-5633 for assistance. Update: A dear surgeon letter was mailed 8/4/08 and provided patient management guidelines. A correction update was sent 8/16/08 with updated surgical technique and instructions for use documents. A dear surgeon letter was mailed 9/25/08 providing additional information regarding the training program.
Quantity in commerce: 19,014 of all products.
Distribution: Nationwide.
Product codes and lots: All units.

Product code KWA

K053536Class IIIDurom Acetabular Component and Metasul Ldh Large Diameter HeadsZimmer GmbH / cleared 2006-03-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)