Events

Recall of MONO-LOK2 PRIMER ACTIVATED ADHESIVE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RMO 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
    41844
  • Event Risk Class
    III
  • Event Initiated Date
    2008-12-09
  • 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
    Company received a customer complaint stating that the opening of the capsule is larger than before and that he uses too much of the product.

Device

MONO-LOK2 PRIMER ACTIVATED ADHESIVE
  • Model / Serial
    Model Catalog: J03241 (Lot serial: 042108)
  • Product Description
    Primer Activated Adhesive Capsules
  • Manufacturer
    RMO INC.

Manufacturer

RMO INC.
  • Manufacturer Address
    DENVER
  • Manufacturer Parent Company (2017)
    Rmo Inc.
  • Source
    HC