Events

Recall of Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System.

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
    79335
  • Event Risk Class
    Class 2
  • Event Number
    Z-1216-2018
  • Event Initiated Date
    2017-10-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162049
  • 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 instruments and stryker leibinger gmbh & co. kg are voluntarily recalling certain serial numbers thoracic pedicle feelers that are used in conjunction with the stryker¿ navigation system because the settings on the machine were higher than intended. this change led to increased energy directed onto the tip of the thoracic pedicle feeler which caused material degradation where the laser marks exist. there is the potential for the tip of the thoracic pedicle feeler to break.
  • Action
    US customers will be notified via FedEx overnight. US Sales Representatives will be notified via email. International entities will be notified via an internal notification system. International customers will be notified per local regulations/procedures. Customer Instructions: Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any affected Thoracic Pedicle Feelers. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you don't have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. If the BRF for your facility indicates that recalled product is currently on hand, we will contact you to arrange for the return of the product for repair/replacement. If discontinuing use of the specific Thoracic Pedicle Feeler(s) listed will cause disruption at your facility. For further questions, please call (269) 323-7700.

Device

Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System.
  • Model / Serial
    Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International , US and US Govt.
  • Product Description
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of || the navigation software and creation of a pathway into the pedicle. The instrument has three || types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The || Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler || tip has been inserted into the pedicle. Next to the navigational information, these depth || indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
  • 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