FDA recall Z-2393-2023

Cytrellis Biosystems, Inc. · Class II · device

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2023-06-23
Report date
2023-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2023