Ellacor System recalled for bearing adhesive defect risk
The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device recall with no reported illnesses or injuries. The hazard is theoretical—a potential bearing adhesive failure that could cause scarring and skin irregularities. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
The FDA is recalling 127 Ellacor System with Micro-Coring Technology devices (Model Gen 4) manufactured by Cytrellis Biosystems, Inc. The recalled devices have a potential bearing adhesive failure in the X/Y stage of the handpiece due to an assembly issue. If the adhesive bond fails, it could cause the cores to overlap during treatment.
This defect could result in prolonged healing and irregularities in patient skin texture, potentially including scarring. The devices were distributed nationwide and are used by medical professionals for treating moderate to severe wrinkles in the mid and lower face in adult patients with Fitzpatrick skin types I-IV. The specific affected serial numbers have been identified by the manufacturer.
Patients who have undergone treatment with affected devices should consult with their treating physician if they experience prolonged healing time, skin texture irregularities, or scarring. Healthcare facilities should identify any affected devices by serial number and secure them.
The recalled product
- Product
- 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
- Manufacturer
- Cytrellis Biosystems, Inc.
- Hazard
- adhesive-failure
- scarring
- skin-irregularity
- prolonged-healing
Distribution
Distributed nationwide across the United States.
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