FDAClass IIJune 7, 2023

Cytrellis ellacor System with Micro-Coring recall

Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in…

Why was Cytrellis ellacor System with Micro-Coring recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: B933ELCON010 All serial numbers

Product
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in…
Recalling firm
Cytrellis Biosystems, Inc.
Quantity
89 units
Distribution
Nationwide
Recall date
June 7, 2023
Classification
Class II
Status
Completed
Agency
FDA (device)
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