Events

Recall of Device Recall Keramos Ceramic/Ceramic Total Hip System

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

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
    32301
  • Event Risk Class
    Class 2
  • Event Number
    Z-1063-05
  • Event Initiated Date
    2005-06-08
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39541
  • 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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented - Product Code MRA
  • Reason
    Labeling on the keramos ceramic femoral heads and liner indicates the product expiration date of 6 years instead of 5 years.
  • Action
    The firm notified all sales agencies and affected products are on return.

Device

Device Recall Keramos Ceramic/Ceramic Total Hip System
  • Model / Serial
    Catalog # 400-01-290/291/292/295/296/297 498-28-048
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA