Z-0546-03

Palacos R radiopaque bone cement, 40 gram. Product number 424800

Name: Z-0546-03 Palacos R radiopaque bone cement, 40 gram. Product number 424800
Creator: Biomet Inc
Published: 2003-01-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2003-01-17 / Terminated / root cause: packaging

FDA source

Biomet Inc began a recall of Palacos R radiopaque bone cement, 40 gram. Product number 424800 on 2003-01-17. The reason FDA records is "There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer". 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-0546-03
Status: Terminated
Initiated: 2003-01-17
Posted: 2003-02-05
Terminated: 2003-09-12
Recalling firm: Zimmer GmbH
Product: Palacos R radiopaque bone cement, 40 gram. Product number 424800.
Product code: LOD Bone Cement
Reason for recall: There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.
Root cause tag: packaging
FDA root cause: Other
Action: The firm issued recall letter for one lot dated January 21, 2003, but a subsequent letter dated January 21, 2003 expanded the recall to all lots. Customers are instructed to not use the product. They are to either return it to their local distributor, or to mix the cement and properly dispose of it themselves. [This is a hazardous material requiring special shipping methods.]
Quantity in commerce: 301,226 units
Distribution: United States
Product codes and lots: All lots.

Product code LOD

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)