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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 DermaPensee related information
Date Initiated by FirmFebruary 05, 2015
Date PostedSeptember 05, 2015
Recall Status1 Terminated 3 on January 31, 2017
Recall NumberZ-2740-2015
Recall Event ID 71149
Product Classification Microneedle Roller/Stamp - Product Code PIU
ProductDermaPen 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
FEI Number 3009081613
Recalling Firm/
Manufacturer		 Derma Pen, LLC
3216 Highland Dr Suite 200
Salt Lake City UT 84106-4178
For Additional Information ContactChad 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
ActionDerma 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 Commerce1,466 units
DistributionWorldwide 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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