Home / Recalls / Cytrellis Biosystems, Inc. / Z-1648-2023

Z-1648-2023 Class II

Recalled by Cytrellis Biosystems, Inc. — Woburn, MA

Recall Details

Product Type: Devices
Report Date: June 7, 2023
Initiation Date: April 7, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 89 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

UDI-DI: B933ELCON010 All serial numbers