Events

Recall of MATRIX CORONAL BENDER

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

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
    54029
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-20
  • 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
    Synthes (canada) ltd. received notification from its supplier synthes usa that a medical device recall was being initiated for the matrix coronal bender part numbers 03.632.040 and 03.632.041 due to complaints received for reported bender tips breaking while surgeons are attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field product consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon).

Device

MATRIX CORONAL BENDER
  • Model / Serial
    Model Catalog: 03.632.040 (Lot serial: LOTS T969999 AND LOWER); Model Catalog: 03.632.041 (Lot serial: LOTS T969999 AND LOWER)
  • Product Description
    MATRIX CORONAL BENDER
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC