Events

Safety Alert for A2FN Reamer

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
    2011-11-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111101.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
    Product recall: synthes a2fn reamer medical device manufacturer, synthes, is initiating a recall for the a2fn reamer (part number: 03.010.368) due to the potential for the drill stop to slip on the reamer. according to the manufacturer, if the drill stop slips on the reamer, it may cause deeper reaming than intended and in very rare cases, penetration of joint space causing pain and / or joint irritation. synthes urged users ceasing use of the affected products. the manufacturer has already changed the design of the a2fn reamer. the new designed reamers are available to replace. according to local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact synthes for necessary actions.

Device

A2FN Reamer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes A2FN Reamer
  • Manufacturer
    Synthes

Manufacturer

Synthes