Reported Jun 7, 2023 · Completed
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of…
Cytrellis Biosystems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cytrellis Biosystems, Inc. · 299 Washington St Ste C · Woburn, MA · 01801-2793
Is this the product you have?
- 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 codes and dates
- UDI-DIB933ELCON010 All serial numbers
- Amount recalled
- 89 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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