Events

Recall of GAP ENDO-EXO MEDULLARY NAIL DRIVER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PEGA MEDICAL 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
    22928
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-10
  • 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
    It appears that breakage of the instrument occurs when bending impaction or excessive torsinal forces are applied on the instrument. the recalled lot numbers were previously reworked and they appear to be moore susceptible to breakage considering that residual stresses may have been generated during the rework.

Device

GAP ENDO-EXO MEDULLARY NAIL DRIVER
  • Model / Serial
    Model Catalog: GAP-NDR100 (Lot serial: 130102-010); Model Catalog: GAP-NDR100 (Lot serial: 110922-052)
  • Product Description
    GAP ENDO-EXO MEDULLARY NAIL DRIVER
  • Manufacturer
    PEGA MEDICAL INC.

Manufacturer

PEGA MEDICAL INC.