Events

Recall of Device Recall Insall/Burstein II Modular Knee System, Tibial Wedge

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
    51219
  • Event Risk Class
    Class 2
  • Event Number
    Z-0555-2010
  • Event Initiated Date
    2009-02-26
  • Event Date Posted
    2009-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79247
  • 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
    knee prosthesis component - Product Code HSX
  • Reason
    Smaller diameter screws than required were included in the package.
  • Action
    Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.

Device

Device Recall Insall/Burstein II Modular Knee System, Tibial Wedge
  • Model / Serial
    Lot 07878240.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.
  • Product Description
    Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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