Events

Safety Alert for Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System

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

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
    2015-03-11
  • Event Date Posted
    2015-03-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150311b.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: synthes gmbh aiming arm 125° and aiming arm 130° for tfn-advanced (tfna) system medical device manufacturer, synthes gmbh, has issued a field safety notice concerning aiming arm 125°for static distal locking (03.037.014) and aiming arm 130° for static distal locking (03.037.013), which are a part of the tfn-advanced (tfna) system. the aiming arms are used with various instruments to assist in the proper alignment of tfna. below are the details of the affected lot products: for aiming arm 125° for static distal locking (03.037.014), the affected lot numbers are 8834516, 8883082, 8909986 for aiming arm 130° for static distal locking (03.037.013), the affected lot numbers are 8803637, 8868571, 8877565, 8903839 the manufacturer discovered that during blade insertion, the tfna guide sleeve has the potential to jam inside of the affected aiming arms which may delay disassembly and/or removal of the instruments. the manufacturer advises users to follow the steps mentioned in the field safety notice to address any occurrences of jamming. the manufacturer is in the process of developing the replacement and recovery plan for indicated devices. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 march 2015.

Device

Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH