Events

Recall of MIDFOOT FUSION BOLT STERILE TITANIUM

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
    94229
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-10
  • 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 is initiating a labelling recall related to the synthes 6.5mm midfoot fusion bolt technique guide. the need was identified for additional clarification in the 6.5mm midfoot fusion bolt technique guide to reduce the potential for bolt back-out or migration by emphasizing the need for supplemental fixation.

Device

MIDFOOT FUSION BOLT STERILE TITANIUM
  • Model / Serial
    Model Catalog: 04.111.205S (Lot serial: n/a); Model Catalog: 04.111.200S (Lot serial: n/a); Model Catalog: 04.111.195S (Lot serial: n/a); Model Catalog: 04.111.190S (Lot serial: n/a); Model Catalog: 04.111.185S (Lot serial: n/a); Model Catalog: 04.111.180S (Lot serial: n/a); Model Catalog: 04.111.175S (Lot serial: n/a); Model Catalog: 04.111.170S (Lot serial: n/a); Model Catalog: 04.111.165S (Lot serial: n/a); Model Catalog: 04.111.160S (Lot serial: n/a); Model Catalog: 04.111.155S (Lot serial: n/a); Model Catalog: 04.111.150S (Lot serial: n/a); Model Catalog: 04.111.260S (Lot serial: n/a); Model Catalog: 04.111.255S (Lot serial: n/a); Model Catalog: 04.111.250S (Lot serial: n/a); Model Catalog: 04.111.245S (Lot serial: n/a); Model Catalog: 04.111.240S (Lot serial: n/a); Model Catalog: 04.111.235S (Lot serial: n/a); Model Catalog: 04.111.210S (Lot serial: n/a); Model Catalog: 04.111.215S (Lot serial: n/a); Model Catalog: 04.111.220S (Lot serial: n/a); Model Catalog: 04.111.230S (Lot serial: n/a); Model Catal
  • Product Description
    MIDFOOT FUSION BOLT STERILE TITANIUM
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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