Events

Recall of CONSERVE BIOFOAM CUP

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
    30373
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-23
  • 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
    Investigation of the metal to metal tha systems shows an increasiung overall trend in revisions from 2009 to present and it was found that there was a specific hazard/harm for suspected tissues reaction to metal debris. the potential for a patient reaction when implanted with metal on metal is a known risk.

Device

CONSERVE BIOFOAM CUP
  • Model / Serial
    Model Catalog: 38BF5460 (Lot serial: > 10 see mfr list); Model Catalog: 38BF4652 (Lot serial: > 10 see mfr list); Model Catalog: 38BF4854 (Lot serial: > 10 see mfr list); Model Catalog: 38BF5056 (Lot serial: > 10 see mfr list); Model Catalog: 38BF5258 (Lot serial: > 10 see mfr list); Model Catalog: 38BF5662 (Lot serial: > 10 see mfr list); Model Catalog: 38BF3642 (Lot serial: > 10 see mfr list); Model Catalog: 38BF4450 (Lot serial: > 10 see mfr list); Model Catalog: 38BF4248 (Lot serial: > 10 see mfr list); Model Catalog: 38BF4046 (Lot serial: > 10 see mfr list); Model Catalog: 38BF3844 (Lot serial: > 10 see mfr list); Model Catalog: 38023844 (Lot serial: > 10 see mfr list); Model Catalog: 38025662 (Lot serial: > 10 see mfr list); Model Catalog: 38024450 (Lot serial: > 10 see mfr list); Model Catalog: 38024248 (Lot serial: > 10 see mfr list); Model Catalog: 38024046 (Lot serial: > 10 see mfr list); Model Catalog: 38024652 (Lot serial: > 10 see mfr list); Model Catalog: 38023642 (Lot serial: > 10 see mfr list
  • Product Description
    CONSERVE BIOFOAM CUP;CONSERVE PLUS THIN SHELL
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD