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
This recall has been completed (originally issued May 26, 2023).
- Company
- Cytrellis Biosystems, Inc.
- Recall Initiated
- April 7, 2023
- Posted
- May 26, 2023
- Recall Number
- Z-1648-2023
- Quantity
- 89 units
- Firm Location
- Woburn, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
UDI-DI: B933ELCON010 All serial numbers
Root Cause
Use error
Action Taken
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