Safety Alert for Bending/Cutting Pliers with Nose for LOCK Plates 2.0

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
    2014-12-19
  • Event Date Posted
    2014-12-19
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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 bending/cutting pliers with nose for lock plates 2.0 medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its bending/cutting pliers with nose for lock plates 2.0 [part number: 329.143; lot number: multiple]. the manufacturer is initiating a voluntary medical device recall of the abovementioned device, which is intended to be used for bending and/or cutting compact 2.0 mandible locking plates. the affected lots of the bending/cutting pliers with nose for lock plates 2.0 have the potential for tip breakage while bending the extra-large compact 2.0 mandible locking plates. the manufacturer advises affected users to immediately identify and quarantine all unused affected 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 19 december 2014.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Bending/Cutting Pliers with Nose for LOCK Plates 2.0
  • Manufacturer

Manufacturer