Events

Recall of Stryker Shape Arm Kit Right

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Stryker Communications Inc.

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
    16450
  • Event Initiated Date
    2014-03-25
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Manufacturer has become aware that there is a remote likelihood of the lock washer and screw that secures the monitor onto the shape arm not to be present. if not present the monitor could separate and dislodge from the arm potentially resulting in injury., the shape arm is an articulating arm for the boom system. it is intended for the mounting/ positioning of a flat panel monitor that is used to view/ perform surgery. the monitor is attached to the shape arm by standard vesa/ tilter bracket that is installed onto the shape arm and is secured with a lock washer and screw., the shape arm does not sustain or support life.
  • Action
    Product to be modified

Device

Stryker Shape Arm Kit Right

Manufacturer

Stryker Communications Inc
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA