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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cytrellis Biosystems, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2393-2023
Related Recalls
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
Cytrellis Biosystems
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.