Home / Recalls / Pinook-Usa / Z-0177-2014

Z-0177-2014 Class II Terminated

Recalled by Pinook-Usa — Orlando, FL

FDA device recall Z-0177-2014 was initiated by Pinook-Usa on May 23, 2013 and is designated Class II. Reason for recall: Failure to submit a premarket submission and gain approval of a medical device. The recall status is terminated (terminated September 29, 2016). Affected quantity: 28,994 units (Micro and Mini).

Recall Details

Product Type: Devices
Report Date: November 13, 2013
Initiation Date: May 23, 2013
Termination Date: September 29, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,994 units (Micro and Mini)

Product Description

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

Reason for Recall

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

Distribution Pattern

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.

Code Information

ALL LOTS