FDA Medical Device Recalls (openFDA)
Biomet Inc: Palacos R radiopaque bone cement, 40 gram. Product number 424800.
- Recall number
- Z-0546-03
- Recalling firm
- Biomet Inc
- Product
- Palacos R radiopaque bone cement, 40 gram. Product number 424800.
- Status
- Terminated
- Initiated
- 2003-01-17
- Posted
- 2003-02-05
- Terminated
- 2003-09-12
- 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
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- not on file
- PMA numbers
- ["P810020"]
- Product code
- LOD
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28