Events

Recall of Cadence Size 5 Left Tibial Tray Implant

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

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
    74173
  • Event Risk Class
    Class 2
  • Event Number
    Z-2086-2016
  • Event Initiated Date
    2016-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146597
  • 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, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
  • Reason
    As a result of an internal review of all labeling for the cadence system, it was determined that the outer package label for the size 5 left tibial tray implant reflects the material composition incorrectly. the labeling incorrectly reflects the material as cobalt chromium instead of titanium.
  • Action
    On 4/29/16, US consignees were notified by electronic mail delivered by traceable method.

Device

Cadence Size 5 Left Tibial Tray Implant
  • Model / Serial
    Cat No. 10207205, Lot: QJ0248
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    NC and PA
  • Product Description
    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.