Events

Recall of Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM

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
    71429
  • Event Risk Class
    Class 2
  • Event Number
    Z-2102-2015
  • Event Initiated Date
    2015-06-02
  • Event Date Posted
    2015-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138120
  • 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
    Instrument, biopsy - Product Code KNW
  • Reason
    Stryker instruments is recalling the stryker selectcore variable throw biopsy device due to the potential for for the stylet to eject from the selectcore device during actuation.
  • Action
    Stryker distributed Customer Notification Letters via Fed Ex overnight to be delivered on 06/10/2015. Customers are asked to Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not 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 this Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Forms; and return the recalled SelectCore devices(s) to Stryker.

Device

Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM
  • Model / Serial
    Stryker Model Number: 0904-410-000; Lot# 61406001
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: TX, NJ and MS.
  • Product Description
    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM || Product Usage: || The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use 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