Events

Recall of LOCATOR IMPLANT ATTACHMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZEST ANCHORS LLC ALSO TRADING AS ZEST ANCHORS INC. AND ZEST ANCHORS.

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
    21256
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-10
  • 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
    The locator abutment and collar for multi-unit assembly (p/n 08909-2)has a specified quantity of 2 units in a package. it has been found that these products were provided with only one vial instead of two as designated by the "-2" suffix in the product's part number which is included on the product label.

Device

LOCATOR IMPLANT ATTACHMENT

Manufacturer

ZEST ANCHORS LLC ALSO TRADING AS ZEST ANCHORS INC. AND ZEST ANCHORS
  • Manufacturer Address
    ESCONDIDO
  • Manufacturer Parent Company (2017)
    Zest Anchors Inc.
  • Source
    HC