Events

Recall of COLLINS RADIOPARENT STERNAL BLADES

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

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
    120619
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-09
  • 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
    The recall has been initiated due to an issue with the device breaking during surgical procedures where the sternum needs to be retracted. the device is breaking where the retractor blade assembles to the stainless steel retractor body. the device is not breaking where it comes in contact with the patient. use of this device may cause a risk to the patient and hospital staff if the device breaks at the retractor blade and retractor body connection point this could prolong the surgery.

Device

COLLINS RADIOPARENT STERNAL BLADES
  • Model / Serial
    Model Catalog: 50-8081 (Lot serial: 296160); Model Catalog: 50-8081 (Lot serial: 244576); Model Catalog: 50-8081 (Lot serial: 296156); Model Catalog: 50-8081 (Lot serial: 296155); Model Catalog: 50-8081 (Lot serial: 296153); Model Catalog: 50-8081 (Lot serial: 296141); Model Catalog: 50-8081 (Lot serial: 296139); Model Catalog: 50-8081 (Lot serial: 296136); Model Catalog: 50-8081 (Lot serial: 276514); Model Catalog: 50-8081 (Lot serial: 276513); Model Catalog: 50-8081 (Lot serial: 268920); Model Catalog: 50-8081 (Lot serial: 268916); Model Catalog: 50-8081 (Lot serial: 244584); Model Catalog: 50-8081 (Lot serial: 244582); Model Catalog: 50-8081 (Lot serial: 296157)
  • Product Description
    Collins Radioparent Sternal Blades Nylon 4 3/4" Long 3" Wide 1 1/2" Deep
  • Manufacturer
    SYMMETRY SURGICAL

Manufacturer

SYMMETRY SURGICAL