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U.S. Department of Health and Human Services

Class 2 Device Recall DermaPen

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  Class 2 Device Recall DermaPen see related information
Date Initiated by Firm February 05, 2015
Date Posted September 05, 2015
Recall Status1 Terminated 3 on January 31, 2017
Recall Number Z-2740-2015
Recall Event ID 71149
Product Classification Microneedle Roller/Stamp - Product Code PIU
Product DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
Code Information All devices on the market
Recalling Firm/
Manufacturer		 Derma Pen, LLC
3216 Highland Dr Suite 200
Salt Lake City UT 84106-4178
For Additional Information Contact Chad A. Milton
800-981-5402 Ext. 101
Manufacturer Reason
for Recall		 Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
FDA Determined
Cause 2		 No Marketing Application
Action Derma Pen sent a notification letter to its customers on February 5, 2015. The purpose of the notification was to inform customers that the FDA issued a warning letter and the steps Derma Pen was taking to address the FDA' s concerns. For further questions please call (800) 981-5402.
Quantity in Commerce 1,466 units
Distribution Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.
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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