Cytrellis ellacor Dermal Micro-Coring System Recalled for Potential Scarring
Cytrellis Biosystems is recalling 89 units of the ellacor System Gen 4 nationwide due to irregular core patterns that may cause prolonged healing, skin texture irregularities, or scarring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for serious harm (scarring and skin texture irregularities) but no reported adverse events or patient injuries to date. Per the rubric, a product with risk of harm where injury has not yet been reported scores at most 3 (High).
Plain-English summary
The Cytrellis ellacor System with Micro-Coring Technology (Model Gen 4) is a dermal device used to treat moderate and severe wrinkles in the mid and lower face. Cytrellis Biosystems, Inc. is recalling 89 units of this device that were distributed nationwide.
The recall is due to an issue with irregular core patterns that could cause potential overlap of cores when the device is set to the 8% setting. This malfunction could lead to prolonged healing time, irregularities in patient skin texture following treatment, and/or scarring.
Healthcare providers and clinics using affected units should discontinue use and contact Cytrellis Biosystems for further guidance. Patients who have undergone treatment with a recalled device should consult with their healthcare provider if they have concerns about healing or post-treatment skin appearance.
The recalled product
- 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
- Manufacturer
- Cytrellis Biosystems, Inc.
- Affected units
- 89
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: B933ELCON010 All serial numbers
Distribution
Distributed nationwide across the United States.
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