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Cytrellis Biosystems, Inc. recalls ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and
Recalled August 16, 2023 · FDA recall Z-2393-2023 · Cytrellis Biosystems
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 · FDA Class II
Units
127 systems
Sold at
Nationwide
Description
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
Product
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
Manufacturer(s)
Cytrellis Biosystems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →