ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the tr...
FDA Device Recall #Z-2393-2023 — Class II — June 23, 2023
Recall Summary
| Recall Number | Z-2393-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 23, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cytrellis Biosystems, Inc. |
| Location | Woburn, MA |
| Product Type | Devices |
| Quantity | 127 systems |
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
Distribution Pattern
Nationwide
Lot / Code Information
UDI = B933ELCON010 S/N: SN 0101 0102 0103 0104 0105 0106 0107 0109 0111 0112 0113 0114 0115 0116 0117 0118 0119 0120 0121 0124 0126 0127 0128 0129 0130 0131 0132 0133 0134 0135 0136 0137 0138 0139 0140 0141 0142 0145 0146 0147 0148 0149 0151 0152 0153 0154 0155 0156 0157 0158 0160 0161 0162 0163 0165 0166 0167 0168 0169 0170 0172 0173 0174 0175 0177 0178 0179 0180 0181 0183 0184 0185 0186 0187 0188 0189 0190 0191 0192 0195 0196 0197 0198 0199 0200 0201 0202 0203 0204 0205 0206 0207 0208 0209 0211 0212 0213 0214 0215 0216 0218 0219 0220 0221 0222 0223 0224 0225 0226 0227 0228 0229 0231 0235 0236 0239 0240 0241 0242 0243 0244 0246 0247 0248 0249 0252 0254
Other Recalls from Cytrellis Biosystems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1648-2023 | Class II | Cytrellis ellacor System with Micro-Coring Tech... | Apr 7, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.