Recall Z-2393-2023 ยท QAI Powered Microneedle Device
Cytrellis Biosystems, Inc.
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
| Date | Aug 11, 2023 (initiated Jun 23, 2023) |
| Status | Open, Classified |
| Reason | Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring |
| Root cause | Process control |
| Action | Cytrellis Biosystems, Inc issued Urgent Medical Device Recall letter via email on 6/23/23 and revised letter on 7/7/23. Letter states reason for recall, health risk and action to take: A member of our service engineering team will be reaching out to your practice to schedule a visit to conduct the software update to your console on site. The visit will take approximately 30-45 minutes. Our goal for the completion of updates for all existing customers is by August 31st. Actions to be taken by the Customer: 1) If you drop or have dropped your handpiece, stop immediate use of the handpiece and co |
| Quantity | 127 systems |
| 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 |