Events

Recall of CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00418-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00418-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The incorrect label was applied to the product that is the subject of this action. certain lots of the chisel blades that were shipped to your facility may be labeled as “not for human use; for veterinary use only”.
  • Action
    The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were supplied may be labelled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY” This action has been closed-out on 03/03/2016.

Device

CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and s...
  • Model / Serial
    CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)Chisel Blade, long, width 10 mmP/N: 399.555Lot numbers: A7OA30, T921923, T933948 & 935423 Chisel Blade, long, width 16 mmP/N: 399.565Lot numbers: A7QA37 & T936951Chisel Blade, long, width 25 mmP/N: 399.575Lot numbers: A7OA36, T937762 & T966630P/N: 399.585Lot numbers: A7OA30 & T939691ARTG number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes