Events

Recall of TESTICULAR IMPLANT SILICONE ELASTOMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDIHUB INTERNATIONAL 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
    133615
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-10
  • 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
    On september 17th 2015 silimed had its ce mark suspended due to the discovery of microscopic particles on the surface of some of its implants tested by tuv in a recent audit. silimed has been given a limit period of 90 days to produce technical reports and treat the non-conformities reported.

Device

TESTICULAR IMPLANT SILICONE ELASTOMER
  • Model / Serial
    Model Catalog: 3232-050 (Lot serial: 8471004); Model Catalog: 3232-045 (Lot serial: 8471004); Model Catalog: 3232-040 (Lot serial: 8471004); Model Catalog: 3232-030 (Lot serial: 8471004); Model Catalog: 3232-050 (Lot serial: 8474209); Model Catalog: 3232-045 (Lot serial: 8474209); Model Catalog: 3232-040 (Lot serial: 8474209); Model Catalog: 3232-030 (Lot serial: 8474209); Model Catalog: 3232-050 (Lot serial: 8474210); Model Catalog: 3232-045 (Lot serial: 8474210); Model Catalog: 3232-040 (Lot serial: 8474210); Model Catalog: 3232-030 (Lot serial: 8474210); Model Catalog: 3232-050 (Lot serial: 8474211); Model Catalog: 3232-045 (Lot serial: 8474211); Model Catalog: 3232-040 (Lot serial: 8474211); Model Catalog: 3232-030 (Lot serial: 8474211); Model Catalog: 3232-050 (Lot serial: ALL LOTS); Model Catalog: 3232-045 (Lot serial: ALL LOTS); Model Catalog: 3232-040 (Lot serial: ALL LOTS); Model Catalog: 3232-030 (Lot serial: ALL LOTS); Model Catalog: 3521-140 (Lot serial: 4442190); Model Catalog: 3521-120 (Lot ser
  • Product Description
    TESTICULAR IMPLANT SILICONE ELASTOMER
  • Manufacturer
    MEDIHUB INTERNATIONAL INC.

Manufacturer

MEDIHUB INTERNATIONAL INC.
  • Manufacturer Address
    AJAX
  • Source
    HC