Cytrellis Biosystems, Inc. recalls ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate an…

Recall date

June 23, 2023

Source

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

Recall number

Z-2393-2023

FDA classification

Class II

Brand / firm

Cytrellis Biosystems, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

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

What was recalled

ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4