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.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide