Events

Recall of OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES

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
    62469
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-10
  • 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. is initiating a voluntary field corrective action/recall of all batches (shipped from september 2013 through october 2016) of the osteoraptor with ultrabraid suture due to a labelling error. the outer box incorrectly states the suture colour as blue the provided suture is white. the inner label is correct.

Device

OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES
  • Model / Serial
    Model Catalog: 72202165 (Lot serial: 50483677); Model Catalog: 72201991 (Lot serial: 50487785); Model Catalog: 72201991 (Lot serial: 50474895)
  • Product Description
    OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES;OSTEORAPTOR 2.3 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.