Recall Z-1648-2023 ยท QAI Powered Microneedle Device
Cytrellis Biosystems, Inc.
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
| Date | May 26, 2023 (initiated Apr 7, 2023) |
| Status | Completed |
| Reason | 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. |
| Root 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 informa |
| Quantity | 89 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202517 | Cytrellis Dermal Micro-Coring System Cytrellis Biosystems, Inc., Jul 9, 2021 |