Events

Recall of Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2012-RN-01019-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01019-1
  • 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 manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable ac3000 spring arm and fallen down together with the monitor until it was only held by the electrical cable connections. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. the frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event.
  • Action
    Stryker Service Technician to inspect and correct Spring Arm Circlips.

Device

Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the ...
  • Model / Serial
    Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)Product numbers: 0682001270, 0682001274, 0682000226 & 06824000591Multiple lot numbers affectedARTG Number: 118878
  • Product Classification
    General and Plastic Surgery Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA