Events

Recall of ACUFIX ANTERIOR CERVICAL PLATE SYSTEM INSTRUMENT TRAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZIMMER SPINE 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
    21277
  • Event Risk Class
    II
  • 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
    It appears there was a confusion regarding the device involved. the device licence #2279 device id #183392 which was entered into mds is not the device involved in the fda recall # z-1038-04.

Device

ACUFIX ANTERIOR CERVICAL PLATE SYSTEM INSTRUMENT TRAY
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    ANT-CER DYNAMIC CERVICAL PLATING SYSTEM
  • Manufacturer
    ZIMMER SPINE INC.

Manufacturer

ZIMMER SPINE INC.
  • Manufacturer Address
    AUSTIN
  • Source
    HC