Recall of NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    86425
  • Event Risk Class
    III
  • Event Initiated Date
    2011-07-25
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Stryker instruments has received reports of casters failing in the field. the caster failures have resulted from the "swivel head of the caster which is a double ball bearing composed of polyamide that loosens over time" creating excessive swivel play. the resultant swivel play allows the caster to bind/jam with the chassis of the rover when force is applied by the operator to move the device.

Device

  • Model / Serial
    Model Catalog: 0702-001-000 (Lot serial: 0733700353)
  • Product Description
    NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER
  • Manufacturer

Manufacturer

  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
  • Source
    HC