Events

Safety Alert for AnspachR Single-use Cutting Burs and Irrigation Clips

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

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
    2011-10-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111004.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
    Field safety notice: synthes anspachr single-use cutting burs and irrigation clips medical device manufacturer, synthes, has issued a field safety notice concerning anspachr single-use cutting burs and irrigation clips used with anspachr electri and pneumatic high speed drill system. this removal is being conducted because anspachr has observed separation between the clear layers of the pouch during real time aging studies. as a result of the separation, it is possible to have a breach in the sterile barrier. this removal action is limited to product that is packaged in a tyvek pouch where the product is retained within a tube. products that are retained within a snap tray are not affected by this removal action. anspachr has not received any reports of incidents or adverse events related to this issue. according to the local supplier, affected products have been distributed in hk. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

AnspachR Single-use Cutting Burs and Irrigation Clips
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Anspach Single-use Cutting Burs and Irrigation Clips
  • Manufacturer
    Synthes

Manufacturer

Synthes