Events

Safety Alert for Offset Cup Impactor Universal

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Brainlab.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-01-16
  • Event Date Posted
    2015-01-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150116.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: brainlab offset cup impactor universal medical device manufacturer, brainlab, has issued a field safety notice concerning brainlab offset cup impactor universal [reference number: 52856/52856a]. the manufacturer identified that when the device is reprocessed according to the instructions in the current brainlab cleaning, disinfection and sterilization guide (revision 4.9 and previous), the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 is not reliably achieved with the currently specified steam sterilization cycles and associated drying times. if a non-sterile offset cup impactor universal is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could enter the patient’s body, potentially leading to infection and serious injury or even death of the patient. the manufacturer advises users to follow newly validated sterilization cycles to achieve the required sterility assurance level (sal) of 10-6. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 january 2015.

Device

Offset Cup Impactor Universal
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Brainlab Offset Cup Impactor Universal
  • Manufacturer
    Brainlab

Manufacturer

Brainlab