Palacos R radiopaque bone cement, 40 gram. Product number 424800.
FDA device recall Z-0546-03 · posted 2003-02-05 · Terminated
Recall details
- Recalling firm
- Biomet Inc
- Reason for recall
- There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.
- Action taken
- 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
- Status
- Terminated
- Product code
- LOD
- Quantity affected
- 301,226 units
- Distribution
- United States
- Date initiated
- 2003-01-17
- Date posted
- 2003-02-05
- Date terminated
- 2003-09-12
- Location
- Warsaw, IN
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