Events

Recall of STANDARD OFFSET CUP IMPACTOR

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

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
    35682
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-29
  • 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
    Greatbatch has determined that when a standard offset cup impactor is sterilized per the current instructions for use (ifu) the device may not be sterile. similarly if the device is removed from the sterilizer after being sent through steam sterilization per the ifu provided it might not remain sterile because it is not completely dry.

Device

STANDARD OFFSET CUP IMPACTOR
  • Model / Serial
    Model Catalog: 2999-63-518 (Lot serial: N/A); Model Catalog: E119814 (Lot serial: N/A); Model Catalog: 2999-60-834 (Lot serial: N/A)
  • Product Description
    Standard Offset Cup Impactor
  • Manufacturer
    GREATBATCH MEDICAL

Manufacturer

GREATBATCH MEDICAL