Events

Recall of ENSEMBLE PROTHESE DE GENOU

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

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
    126799
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-16
  • 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
    These packs contain laparotomy sponges that have been recalled by medtronic (covidien curity curity x-ray kerlix x-ray vistec x-ray). medtronic states that the seal integrity of the lap sponge package may be compromised resulting in potential breach of the sterile barrier. this could lead to an increased risk of infection. medtronic reports no adverse incidents associated with this issue. medline canada has not received any complaints of this nature.

Device

ENSEMBLE PROTHESE DE GENOU
  • Model / Serial
    Model Catalog: DYNJ39495X (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DYNJ23232X (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ENSEMBLE PROTHESE DE GENOU;GRACE HYSTERECTOMY PACK
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION