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Cytrellis Biosystems Recalls
2 recalls on record · June 7, 2023 to August 16, 2023 · Medical Devices
August 16, 2023Medical DevicesFDA
Cytrellis Biosystems, Inc. recalls ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and
Hazard: 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
June 7, 2023Medical DevicesFDA
Cytrellis Biosystems, Inc. recalls Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of mo
Hazard: 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.