Events

Recall of STANDARD OFFSET CUP IMPACTOR

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

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
    126181
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-11
  • 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 had originally identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use (ifu) provided with the device. the standard offset cup impactor is provided non-sterile and must be sterilized prior to use in a surgery. stryker orthopedics then took additional risk mitigation steps to include the removal of the blue plastic handle. all modified units (t6318) are now being removed from the field.

Device

STANDARD OFFSET CUP IMPACTOR
  • Model / Serial
    Model Catalog: T6318 (Lot serial: ALL)
  • Product Description
    STANDARD OFFSET CUP IMPACTOR
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC