Recall Z-1648-2023— Cytrellis Biosystems, Inc.

Name: FDA recall Z-1648-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-07

Class II · Completed

Class II FDA medical device recall by Cytrellis Biosystems, Inc., initiated 2023-04-07. It names one FDA 510(k) clearance: K202517. Product: 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. Reason: 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..

Recalling firm: Cytrellis Biosystems, Inc.
Classification: Class II
Status: Completed
Initiated: 2023-04-07
Firm location: Woburn, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K202517 — Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc.·cleared 2021-07-09

K-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

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.