BEUDAMED
    FDA Recall Terminated

    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.

    Recall: Z-0177-2014 · Initiated May 23, 2013

    Recall

    Recall Number
    Z-0177-2014
    Event Number
    66191
    Firm
    Pinook-Usa
    FEI Number
    3008113239
    Product Code
    NGX
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    May 23, 2013
    Posted
    November 7, 2013
    Terminated
    September 29, 2016
    Address
    901 Central Florida Pkwy, Ste A6, Orlando, FL, 32824-8508

    Description

    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.

    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: [email protected] 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.

    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.

    Quantity

    28,994 units (Micro and Mini)