FDA Device

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

Hazard

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

What You Should Do

Remedy

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.]

Products

Palacos R radiopaque bone cement, 40 gram. Product number 424800.
Brand
Biomet Inc
UPC
All lots.

Units Affected

301,226 units