Events

Recall of REFLECTION ACETABULAR SYSTEM - SCREW

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW INC..

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
    66178
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-06
  • 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
    Smith & nephew inc. has initiated a voluntary recall of a single batch/lot of the reflection spherical head screw 25mm due to a packaging error. the labels correctly state that the product should be a 25mm screw but the box contained a longer 35mm screw. the catalog item number and description on the label are aligned but the wrong product is inside the box.

Device

REFLECTION ACETABULAR SYSTEM - SCREW
  • Model / Serial
    Model Catalog: 71332525 (Lot serial: 16AM14274)
  • Product Description
    REFLECTION ACETABULAR SYSTEM - SCREW
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.