Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of mo
FDA device recall Z-1648-2023 · posted 2023-05-26 · Completed
Recall details
- Recalling firm
- Cytrellis Biosystems, Inc.
- 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.
- 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
- Root cause
- Use error
- Status
- Completed
- Product code
- QAI
- Quantity affected
- 89 units
- Distribution
- Nationwide
- Date initiated
- 2023-04-07
- Date posted
- 2023-05-26
- Location
- Woburn, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cytrellis Dermal Micro-Coring System (K202517) | Cytrellis Biosystems, Inc. | 2021-07-09 |