Events

Recall of Device Recall Bigliani/Flatow

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    33279
  • Event Risk Class
    Class 2
  • Event Number
    Z-0029-06
  • Event Initiated Date
    2005-08-23
  • Event Date Posted
    2005-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41607
  • 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, Shoulder, Semi-Constrained, Metal/Polymer Cemented - Product Code KWS
  • Reason
    The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
  • Action
    Consignees were notified via letter dated August 23, 2005 or by email.

Device

Device Recall Bigliani/Flatow
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Australia, Canada, England, Germany and Italy.
  • Product Description
    Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA