Events

Recall of Stryker Neptune 1 and Neptune 2 Waste Management Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zeppessis Reprocessing, LLC.

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
    66176
  • Event Risk Class
    Class 2
  • Event Number
    Z-2212-2013
  • Event Initiated Date
    2013-08-16
  • Event Date Posted
    2013-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121629
  • 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
    Zeppessis' reprocessed single-use manifolds (filters) for the stryker neptune 1 and neptune 2 waste management systems are recalled due to lacking 510k and and without a validated cleaning protocol for reprocessing the used manifolds.
  • Action
    Zeppessis Reprocessing, LLC sent an Urgent Medical Device Recall letter dated September 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to stop using the Zeppessis reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems immediately and instructed to destroy the products in a proper manner. Customers should fill out the Customer Response form and fax or email it back to Zeppessis. For any questions about this recall, please call Zeppessis Reprocessing, LLC at 208-559-7064.

Device

Stryker Neptune 1 and Neptune 2 Waste Management Systems
  • Model / Serial
    -Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000);  -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000);  -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of California, Idaho, Oregon, and Washington.
  • Product Description
    Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: || The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump.
  • Manufacturer
    Zeppessis Reprocessing, LLC

Manufacturer

Zeppessis Reprocessing, LLC
  • Manufacturer Address
    Zeppessis Reprocessing, LLC, 121 E 38th St Ste 101, Garden City ID 83714-6495
  • Source
    USFDA