Events

Recall of Device Recall Neptune 2 Rover Ultra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    63634
  • Event Risk Class
    Class 2
  • Event Number
    Z-0455-2013
  • Event Initiated Date
    2011-05-24
  • Event Date Posted
    2012-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114396
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Reason
    Beginning may 24, 2011 stryker neptune 2 (n2) waste management systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the rover's ability to roll. this can result in additional strain on the operator, due to multiple exposures resulting in back pain.
  • Action
    Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to sales.service@stryker.com. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.

Device

Device Recall Neptune 2 Rover Ultra
  • Model / Serial
    Part 0702-002-000 (230v)   Lot 0733700353 through 1036100423
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
  • Product Description
    Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A || REF 0702-002-000, Rx Caution, consult accompanying documents || Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, || The Neptune Waste Management System consists of a mobile rover unit || used to suction and collect fluid waste, small debris and electrocautery || smoke from a surgical site. Mobility allows the rover unit to be || relocated to a waste disposal area where the rovers collection canisters || can be emptied, via the docking station. || Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA