Events

Recall of Device Recall SpineNet Bone Marrow Aspiration Needle Kit

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

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
    65914
  • Event Risk Class
    Class 2
  • Event Number
    Z-2107-2013
  • Event Initiated Date
    2013-02-04
  • Event Date Posted
    2013-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120840
  • 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
    Needle, aspiration and injection, disposable - Product Code GAA
  • Reason
    Spinenet was marketing this device to be used with spinenet acc device without fda clearance or approval.
  • Action
    SpineNET sent a "VOLUNTARY PRODUCT RECALL" letter dated 02/04/2013 to Halifax Medical Center. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 407-539-2483 for questions regarding this notice.

Device

Device Recall SpineNet Bone Marrow Aspiration Needle Kit
  • Model / Serial
    Lot # 22754F16 and #25854I17
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to one customer in Florida.
  • Product Description
    SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). || Use to aspirate bone morrow.
  • Manufacturer
    SpineNet

Manufacturer

SpineNet
  • Manufacturer Address
    SpineNet, 1300 Minnesota Ave, Suite 200, Winter Park FL 32789-4800
  • Manufacturer Parent Company (2017)
    Spinenet Llc
  • Source
    USFDA