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

FDA device recall Z-0176-2014 · posted 2013-11-07 · Terminated

Recall details

Recalling firm

Pinook-Usa

Reason for recall

Failure to submit a premarket submission and gain approval of a medical device.

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

NGX

Quantity affected

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.

Date initiated

2013-05-23

Date posted

2013-11-07

Date terminated

2016-09-29

Location

Orlando, FL