Events

Recall of Device Recall Stryker FlowPort II Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    74070
  • Event Risk Class
    Class 2
  • Event Number
    Z-1910-2016
  • Event Initiated Date
    2016-05-04
  • Event Date Posted
    2016-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146181
  • 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
    OR - Orthopedic - Product Code NBH
  • Reason
    Complaints were received for the stryker flowport ii adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction.
  • Action
    A recall letter was not sent as all affected devices have been returned. A ship hold was placed on the device on October 16, 2015.

Device

Device Recall Stryker FlowPort II Adapter
  • Model / Serial
    Lot Numbers Affected: 13604
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    GA, UT, MD, NJ, MT
  • Product Description
    Stryker FlowPort II Adapter: Model number: 00CAT00778 || The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • Manufacturer Address
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA