Class 2 Device Recall Cytrellis ellacor System

• Date Initiated by Firm: April 07, 2023
• Date Posted: May 26, 2023
• Recall Status: 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: 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