# FDA recall Z-2393-2023

> **Cytrellis Biosystems, Inc.** · Class II · device recall initiated 2023-06-23.

## 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 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

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2393-2023
- **Recalling firm:** Cytrellis Biosystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-23
- **Report date:** 2023-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2023

## Citation

> AI Analytics. FDA recall Z-2393-2023. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-2393-2023. Source: US FDA. Licensed CC0.

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