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Terminated

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

FDA Recall Z-0546-03 · Posted 2003-02-05

Recalling FirmBiomet Inc
Recall StatusTerminated
Product CodeLOD
Date Initiated2003-01-17
Date Terminated2003-09-12
Product Quantity301,226 units

Reason for Recall

There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.

Firm 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.]

Root Cause

Other

Distribution Pattern

United States

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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