Cytrellis Biosystems recalls its ellacor Dermal Micro-Coring System for potential skin irregularities at 8% setting. Affected units have model Gen 4 with serial numbers starting B933ELCON010.
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.
Cytrellis Biosystems recalls its ellacor Dermal Micro-Coring System for potential skin irregularities at 8% setting. This could lead to prolonged healing, skin texture issues, or scarring. The recall affects specific model units sold with serial numbers starting with B933ELCON010.
The device's core patterns might overlap at the 8% setting, causing longer healing times, uneven skin texture, or scarring. This happens due to irregular core patterns in the micro-coring system.
People who own the Gen 4 model with serial numbers starting B933ELCON010 are affected. Those using the device for facial wrinkle treatment are most at risk.
Check for the Gen 4 model with serial numbers starting with B933ELCON010. The device is intended for treating moderate and severe facial wrinkles.
Look for serial numbers starting with B933ELCON010 on the device.
The recalled device is the Gen 4 model with serial numbers starting with B933ELCON010.
Irregular core patterns could cause potential overlap of cores, leading to prolonged healing, skin texture irregularities, or scarring.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Cytrell:ellis to request your refund or repair — edit it as you like.
Subject: Recall Z-1648-2023 — Cytrell:ellis Cytrell:ellis Hello, I own a Cytrell:ellis that is covered by recall Z-1648-2023 from Cytrell:ellis. 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.