Recalls / —

—#25929

Product

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

FDA product code

LOD — Bone Cement

Device class

Class 2

Medical specialty

Orthopedic

PMA numbers

P810020

Affected lot / code info

All lots.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.]

Recalling firm

Firm

Biomet Inc

Address

56 East Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern

United States

Timeline

Recall initiated

2003-01-17

Posted by FDA

2003-02-05

Terminated

2003-09-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25929. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.