Device recall
Z-2393-2023: ellacor System with Micro-Coring Technology-Indicated for use by medical…
FDA device recall · Class II · Cytrellis Biosystems, Inc.
Key facts
| Recall number (Z-number) | Z-2393-2023 |
|---|---|
| Recall event | 92689 |
| 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 |
| Product code | QAI |
| Recalling firm | Cytrellis Biosystems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K202517 |
| FEI number | 3020704367 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database