Events

Recall of CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and/or bone fragments)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Wright Medical Australia Pty Ltd.

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-2014-RN-00914-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00914-1
  • 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
    As an outcome of an investigation from a field complaint, wright medical discovered that certain claw and claw ii plates were manufactured from an incorrect raw material. the raw material specified for claw and claw ii plates is stainless steel meeting the requirements of astm f139 in a cold worked condition, however the material used meets the requirements of astm f139 stainless steel, but is in an annealed condition, which has reduced strength and increased ductility.
  • Action
    Wright Medical is recalling affected stock from hospitals. Additionally, Wright Medical is advising surgeons that if the intended postoperative instructions are followed by the patient, the product will still perform as intended. If the patient does not follow instructions and bears weight on the plate prior to fusion the ductility of the material may increase the likelihood of malunion or non-union. Prophylactic revision surgery is not recommended. For more details, please see http://www.tga.gov.au/safety/alerts-device-claw-plates-140829.htm . This action has been closed-out on 16/05/2017.

Device

CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and...
  • Model / Serial
    CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and/or bone fragments)CLAW 3.5MM PLATE 2 HOLE 30MM (40130130);CLAW PLATE 20MM INTERAXIS (40S20020);CLAW II 2 HOLE 15MM (40240215), 20MM (40240220), 25MM (40240225), 30MM (40240230);CLAW II STRAIGHT20 X 20MM (40242020), 20 X 25MM (40242025), 25 X 25MM (40242525). (Catalog Numbers in brackets)Multiple lot numbers affectedARTG Number: 198485
  • Product Classification
    Orthopedic Devices
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd