Recall Z-0546-03 ยท LOD Bone Cement
Biomet Inc
Palacos R radiopaque bone cement, 40 gram. Product number 424800.
| Date | Feb 5, 2003 (initiated Jan 17, 2003) |
| Status | Terminated |
| Reason | There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer. |
| 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 | 301,226 units |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.