Cytrellis Biosystems, Inc. recalls Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of m…

Recall date

April 7, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1648-2023

FDA classification

Class II

Brand / firm

Cytrellis Biosystems, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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