Cytrellis recalls ellacor System with Micro-Coring Technology for possible core overlap causing skin irregularities or scarring after moderate wrinkle treatment. Affected models include Gen 4 units with specific serial numbers.
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
Cytrellis recalls its ellacor System device for medical use on wrinkles. A bearing adhesive joint issue could cause cores to overlap, leading to skin texture problems or scarring after treatment.
The device's X/Y stage bearing adhesive joint may fail due to assembly issues. If the glue bond breaks, it could cause cores to overlap, resulting in prolonged healing, skin texture irregularities, or scarring.
Medical professionals using the ellacor System for treating moderate wrinkles in adults aged 22+ with Fitzpatrick skin types I-IV. Those with the specific Gen 4 model and serial numbers listed are most at risk.
Check for the Gen 4 model with serial numbers starting with 0101 through 0254. The device is intended for medical professionals treating wrinkles in adults 22+ with Fitzpatrick skin types I-IV.
Verify the device is a Gen 4 model with serial numbers listed in the recall notice.
Reach out to Cytrellis Biosystems for specific guidance on whether your device is affected.
No, this device is intended for medical professionals only and not for home use.
If the bearing adhesive joint fails, it could cause cores to overlap, potentially leading to prolonged healing, skin texture irregularities, or scarring.
Check for the Gen 4 model with serial numbers starting from 0101 to 0254 as listed in the recall notice.
We’ve drafted a message you can send Cytrellis to request your refund or repair — edit it as you like.
Subject: Recall Z-2393-2023 — Cytrellis Cytrellis Hello, I own a Cytrellis that is covered by recall Z-2393-2023 from Cytrellis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
