Events

Recall of CONSERVE PLUS SHELL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MICROPORT ORTHOPEDICS 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
    101143
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-04
  • 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
    Microport orthopedics inc. removed part numbers 38025060 38025662 and 38025664 from an approved canadian license in november 2014. no product performance activity occurred for the resurfacing indication related to removal of these parts from the license. in december 2017 microport orthopedics inc. was made aware that the products were sold into canada after the november 2014 date of product removal from the license.

Device

CONSERVE PLUS SHELL
  • Model / Serial
    Model Catalog: 38025664 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 38025662 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 38025060 (Lot serial: 0952489251593795)
  • Product Description
    CONSERVE PLUS SHELL;CONSERVE PLUS THICK CUPS
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD