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U.S. Department of Health and Human Services

Class 2 Device Recall Pinook Mini Massager

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  Class 2 Device Recall Pinook Mini Massager see related information
Date Initiated by Firm May 23, 2013
Date Posted November 07, 2013
Recall Status1 Terminated 3 on September 29, 2016
Recall Number Z-0176-2014
Recall Event ID 66191
Product Classification Stimulator, muscle, powered, for muscle conditioning - Product Code NGX
Product Pinook Mini Massager
Distributed by www.pinookusa.com.

Used to strengthen the abdominal muscles.
Code Information ALL LOTS
Recalling Firm/
Manufacturer		 Pinook-Usa
901 Central Florida Pkwy Ste A6
Orlando FL 32824-8508
For Additional Information Contact Sheva Ben-Shushan
407-854-0055 Ext. 301
Manufacturer Reason
for Recall		 Failure to submit a premarket submission and gain approval of a medical device.
FDA Determined
Cause 2		 No Marketing Application
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.
Quantity in Commerce 28,994 units (Mini and Micro)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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