Events

Recall of Device Recall Navigation System IICart with Articulated Arm Camera

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
    71268
  • Event Risk Class
    Class 2
  • Event Number
    Z-1810-2015
  • Event Initiated Date
    2015-05-04
  • Event Date Posted
    2015-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137176
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Reason
    Stryker initiated a device recall of the navigation system ii-cart, camera articulated arm because there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in a potential failure of the arm joint.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification letter dated May 18, 2013 to Domestic customers notice via FedEx overnight and Sales Representatives via email. The International Subsidiaries will also be notified via email. Customers are instructed to immediately review the Recall Notification adn complete the following: Immediately check all stock areas and/or operating room storage for affected equipment found. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many affected items are currently in inventory. Please complete and return the BRF even if they dont have any affected product on hand. If customers have further distributed this product, they are asked to forward this letter and the attached BRF to all affected locations. Please indicate each location and serial number(s) on the BRF. Fax (866-521-2762) or email (kellyjo.davis@stryker.com) the completed BRF to Stryker Instruments Regulatory Department, Attn: Kelly Jo Davis. A Stryker Representative will contact the facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera.

Device

Device Recall Navigation System IICart with Articulated Arm Camera
  • Model / Serial
    Serial numbers 100019, 100984, 100965, 100295, 100979, 100773, 100946, 100797, 100947, 100956, 100966, 100649, 100967, 100944, 100941, 100945, 100970, 100950, 100976, 100951, 100728, 100952, 100248, 100953, 100641, 100954, 100463, 100955, 100981, 100957, 100978, 100958, 100106, 100959, 100939, 100960, 100973, 100961, 100236, 100962, 100237, 100963, 100417, 100964. 100940, 100968, 100975, 100969, 100977, 100972, 100105, 100974, 100214, 100980, 100492, 100982, 100493, 100983, 100948, 100986, 100704, 100987, 100949, 100988, 100227, 100989, 100971, 100133, 100134, 100942.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY and the countries of Canada, Europe, and Asia.
  • Product Description
    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U || Product Usage: || The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
  • 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