Z-1648-2023 Class II
FDA device recall Z-1648-2023 was initiated by Cytrellis Biosystems, Inc. on April 7, 2023 and is designated Class II. 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. Affected quantity: 89 units.
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