Events

Recall of SOFT TISSUE GAUGE- 6 MM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COCHLEAR BONE ANCHORED SOLUTIONS AB.

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
    70069
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-18
  • 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
    Recall initiated due to manufacturing imperfection in the smooth surface of the metal on the soft tissue gauge which resulted in small visible sharp edges and burrs.

Device

SOFT TISSUE GAUGE- 6 MM
  • Model / Serial
    Model Catalog: 95070 (Lot serial: COH485876); Model Catalog: 95070 (Lot serial: 131008)
  • Product Description
    Soft Tissue Gauge- 6 mm
  • Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB

Manufacturer

COCHLEAR BONE ANCHORED SOLUTIONS AB
  • Manufacturer Address
    MOLNLYCKE
  • Manufacturer Parent Company (2017)
    Cochlear Ltd.
  • Source
    HC