Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of mo
Summary
The FDA issued a Class II for Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System by Cytrellis Biosystems, Inc.. Reason: Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient .
Details
Source
Device Recall
External ID
Z-1648-2023
Action Date
2023-06-07
Status
Completed
Category
device
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
Lot/Code Info: UDI-DI: B933ELCON010 All serial numbers
Quantity Affected: 89 units
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
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-07
Company
Woburn, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cytrellis Biosystems, Inc. has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cytrellis Biosystems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cytrellis Biosystems, Inc. have FDA actions?
Cytrellis Biosystems, Inc. has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1648-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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