Recall Z-2393-2023— Cytrellis Biosystems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Cytrellis Biosystems, Inc., initiated 2023-06-23. It names one FDA 510(k) clearance: K202517. 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. Reason: 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.
- Recalling firm
- Cytrellis Biosystems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-23
- Firm location
- Woburn, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.