Events

Recall of Device Recall Palacos R

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25497
  • Event Risk Class
    Class 2
  • Event Number
    Z-0546-03
  • Event Initiated Date
    2003-01-17
  • Event Date Posted
    2003-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25929
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bone Cement - Product Code LOD
  • Reason
    There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.
  • 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.]

Device

Device Recall Palacos R
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States
  • Product Description
    Palacos R radiopaque bone cement, 40 gram. Product number 424800.
  • Manufacturer
    Biomet Inc

Manufacturer

Biomet Inc
  • Manufacturer Address
    Biomet Inc, 56 East Bell Dr, Warsaw IN 46582
  • Source
    USFDA