Events

Recall of RCI ACL FIXATION 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
    56046
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-30
  • 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 is initiating a voluntary field corrective action/recall of various batches of the rci screw due to a carton label error. the carton label incorrectly identifies the screw as a "reverse thread" screw. the screw presented in the package is a standard thread screw which is correctly identified on the inner pouch label. in the event the screw is presented for use the user would notice that the device is not a reverse thread screw. the user would replace the screw or use the provided screw to complete the procedure using a clockwise rotation.

Device

RCI ACL FIXATION SCREW
  • Model / Serial
    Model Catalog: 7209409 (Lot serial: 50617125); Model Catalog: 7209409 (Lot serial: 50604301); Model Catalog: 7209409 (Lot serial: 50576152)
  • Product Description
    RCI ACL FIXATION SCREW
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.