Events

Recall of Device Recall Pinook Mini Massager

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

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
    66191
  • Event Risk Class
    Class 2
  • Event Number
    Z-0176-2014
  • Event Initiated Date
    2013-05-23
  • Event Date Posted
    2013-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122609
  • 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
    Stimulator, muscle, powered, for muscle conditioning - Product Code NGX
  • Reason
    Failure to submit a premarket submission and gain approval of a medical device.
  • Action
    On October 18, 2013 the firm sent the following notification to their customers: This is to inform you of a product recall involving: Pinooks Mini-massager and Pinooks Micro Massager model number PT-11 See enclosed product label (for ease in identifying the product at retail/user level). This recall has been initiated due to failure to submit a premarket submission and gain approval. We began shipping this product on 11/27/2012. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Pinook USA is removing the products (mini and micro massager) from the market until receiving FDA approval to market them again under a new 510(k). If you have stock on your end please return them to our office: 901 C FL PKWY STE A6, Orlando FL, 32824. Before returning, please contact Sheva Ben-Shushan: accounting@pinookusa.com in order to receive an RMA number. Once you have RMA number, place that number on the package label. This recall should be carried out to the retail level. Your assistance is appreciated and necessary to prevent patient harm. If you have any questions, call Dvir Lev-Ran, telephone number: 407-854-0055 Ext 304. This recall is being made with the knowledge of the Food and Drug Administration.

Device

Device Recall Pinook Mini Massager
  • Model / Serial
    ALL LOTS
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.
  • Product Description
    Pinook Micro Massager || Distributed by www.pinookusa.com || Used to strengthen the abdominal muscles.
  • Manufacturer
    Pinook-Usa

Manufacturer

Pinook-Usa
  • Manufacturer Address
    Pinook-Usa, 901 Central Florida Pkwy Ste A6, Orlando FL 32824-8508
  • Source
    USFDA