Events

Recall of ACTIFUSE ABX

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

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
    80888
  • Event Risk Class
    I
  • Event Initiated Date
    2015-08-19
  • 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
    Baxter corporation is issuing a recall of actifuse abx products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria.

Device

ACTIFUSE ABX
  • Model / Serial
    Model Catalog: 506005078109 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 506005078107 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 506005078108 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Classification
    Orthopedic Devices
  • Product Description
    ACTIFUSE ABX
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION