Events

Recall of Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes 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-01366-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01366-1
  • 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 cheek retractor for matrixmandible u-shaped may not function as intended due to the potential for corrosion and/or failure of the internal spring which has been manufactured from an incorrect material. as an internal part of the instrument, the spring is not in direct contact with the patient. however, in the event that the spring or a subcomponent of the spring was to fail and/or corrode, the possibility exists that the particles may transfer from the instrument to the patient, potentially leading to an adverse tissue reaction and/or infection. a surgical delay may also arise if the retractor does not work during a procedure and a replacement needs to be found.To date, there have been no reports of adverse events related to this issue.
  • Action
    Customers are asked to inspect invetory and to follow the instructions provided for any affected units. To mitigate risk, should customers with affected instruments require the instrument for emergency cases, please perform a visual and functional inspection, as detailed in the cistomer letter, prior to, during and after use. Customers are asked to exercise caution regarding the risk of corrosion or spring breaking during the procedure. This action has been closed-out on 04/04/2017.

Device

Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
  • Model / Serial
    Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexiblePart Number: 397.232Multiple lot numbers affectedARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd