Events

Recall of DIRECT DRIVE DISPOSABLE GRASPER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOUTHMEDIC 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
    72546
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-18
  • 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
    Possible discrepancies in the in the material drying time and consequent injection molding. parameters during the manufacture of the respective locking trigger lots. as a result of these non-conformities there is potential.For the locking trigger to fracture during usage and allow the grasper to remain in a closed position. all units/kits that were built with the suspect lots of triggers have either been put in quarantine or are included in the recall.

Device

DIRECT DRIVE DISPOSABLE GRASPER
  • Model / Serial
    Model Catalog: C4130 (Lot serial: 1137511); Model Catalog: C4130 (Lot serial: 1127581); Model Catalog: C4130 (Lot serial: 1126120)
  • Product Description
    Direct Drive Grasper
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.