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U.S. Department of Health and Human Services

Class 2 Device Recall Cytrellis ellacor System

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  Class 2 Device Recall Cytrellis ellacor System see related information
Date Initiated by Firm April 07, 2023
Date Posted May 26, 2023
Recall Status1 Completed
Recall Number Z-1648-2023
Recall Event ID 92187
510(K)Number K202517  
Product Classification Powered microneedle device - Product Code QAI
Product Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face.
Model #: Gen 4
Code Information UDI-DI: B933ELCON010 All serial numbers
Recalling Firm/
Manufacturer		 Cytrellis Biosystems, Inc.
299 Washington St Ste C
Woburn MA 01801-2793
Manufacturer Reason
for Recall		 Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.
FDA Determined
Cause 2		 Use error
Action Cytrellis issued Medical Device Update / Product Notification Letter via email on 4/7/23. Letter states reason for recall, heath risk and action to take: Important information is included in the new Quick Reference Guide, with emphasis on the following points: "DO NOT impede tubing on handpiece. "DO NOT apply forceful downward pressure. "DO NOT TOUCH needle cartridge tubing while treating patient. Your PDM will be reaching out soon to set up time with you and your staff to review the Quick Reference Guide, and we would also like to invite you to join our medical team in one of two live informative webinars to review best practices and answer any questions that you might have. These webinars will be hosted by our Medical Director, Dr. Ashish Bhatia, along with the Cytrellis Medical Affairs team. Invitations to the webinars will be sent shortly. For additional information or inquiries, please email medicalinformation@cytrellis.com
Quantity in Commerce 89 units
Distribution Nationwide
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.
510(K) Database 510(K)s with Product Code = QAI and Original Applicant = Cytrellis Biosystems, Inc.
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