Events

Recall of HINTEGRA REVISION TALAR COMPONENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTEGRA CANADA ULC..

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
    70423
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-26
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Newdeal sas a company within integra lifesciences group has recently identified through an internal evaluation a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch thus posing the risk of a potential patient infection.

Device

HINTEGRA REVISION TALAR COMPONENT
  • Model / Serial
    Model Catalog: 301 121 (Lot serial: ALL LOTS); Model Catalog: 301 200 (Lot serial: ALL LOTS); Model Catalog: 301 202 (Lot serial: ALL LOTS); Model Catalog: 301 203 (Lot serial: ALL LOTS); Model Catalog: 302 125 (Lot serial: ALL LOTS); Model Catalog: 302 124 (Lot serial: ALL LOTS); Model Catalog: 302 123 (Lot serial: ALL LOTS); Model Catalog: 302 122 (Lot serial: ALL LOTS); Model Catalog: 302 121 (Lot serial: ALL LOTS); Model Catalog: 301 125 (Lot serial: ALL LOTS); Model Catalog: 301 124 (Lot serial: ALL LOTS); Model Catalog: 301 123 (Lot serial: ALL LOTS); Model Catalog: 301 122 (Lot serial: ALL LOTS); Model Catalog: 301 201 (Lot serial: ALL LOTS); Model Catalog: 302 206 (Lot serial: ALL LOTS); Model Catalog: 302 205 (Lot serial: ALL LOTS); Model Catalog: 302 204 (Lot serial: ALL LOTS); Model Catalog: 302 203 (Lot serial: ALL LOTS); Model Catalog: 302 202 (Lot serial: ALL LOTS); Model Catalog: 302 201 (Lot serial: ALL LOTS); Model Catalog: 302 200 (Lot serial: ALL LOTS); Model Catalog: 301 206 (Lot serial:
  • Product Description
    HINTEGRA REVISION TALAR COMPONENT
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.