Events

Recall of ENDOLITE 30MM PYRAMID ADAPTER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BLATCHFORD PRODUCTS 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
    25040
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-01
  • 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
    A small number of failures (0.85%) have been reported where components have cracked unexpectedly both at the fitting stage and after a period of use. similar failures could result in the limb wearer falling and injuring themselves.

Device

ENDOLITE 30MM PYRAMID ADAPTER
  • Model / Serial
    Model Catalog: 409028 (Lot serial: S001 TO S365); Model Catalog: 409054 (Lot serial: R001 TO R365); Model Catalog: 409028 (Lot serial: R001 TO R365); Model Catalog: 409054 (Lot serial: Q001 TO Q365); Model Catalog: 409054 (Lot serial: S001 TO S365); Model Catalog: 409054 (Lot serial: P265 TO P365); Model Catalog: 409028 (Lot serial: P265 TO P365); Model Catalog: 409054 (Lot serial: T001 TO T048); Model Catalog: 409028 (Lot serial: T001 TO T048); Model Catalog: 409028 (Lot serial: Q001 TO Q365)
  • Product Description
    ENDOLITE 30MM PYRAMID CLAMP ADAPTORS
  • Manufacturer
    BLATCHFORD PRODUCTS LTD

Manufacturer

BLATCHFORD PRODUCTS LTD