Reported Aug 16, 2023 · Ongoing
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate…
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?
- ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
- Lot codes and dates
- UDI =
- B933ELCON010 S/NSN
127 of 127 codes
010101020103010401050106010701090111011201130114011501160117011801190120012101240126012701280129013001310132013301340135013601370138013901400141014201450146014701480149015101520153015401550156015701580160016101620163016501660167016801690170
- Amount recalled
- 127 systems
Where it was sold
- Nationwide
Why it was recalled
Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and 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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