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Recall Observatory FDA recall evidence

Device product

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

Z-1648-2023

April 07, 2023

Class II

Product summary

Firm
Cytrellis Biosystems, Inc.
Event
Event 92187
Status
Completed
Classification
Class II
Quantity
89 units
Official record key
device-enforcement:Z-1648-2023

Official wording

Reason: 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.

Code information: UDI-DI: B933ELCON010 All serial numbers

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.