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U.S. Department of Health and Human Services

Class 2 Device Recall Cytrellis Biosystems

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 Class 2 Device Recall Cytrellis Biosystemssee related information
Date Initiated by FirmJune 23, 2023
Date PostedAugust 11, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2393-2023
Recall Event ID 92689
510(K)NumberK202517 
Product Classification Powered microneedle device - Product Code QAI
Productellacor 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
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
Recalling Firm/
Manufacturer
Cytrellis Biosystems, Inc.
299 Washington St Ste C
Woburn MA 01801-2793
Manufacturer 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
FDA Determined
Cause 2
Process control
ActionCytrellis Biosystems, Inc issued Urgent Medical Device Recall letter via email on 6/23/23 and revised letter on 7/7/23. Letter states reason for recall, health risk and action to take: A member of our service engineering team will be reaching out to your practice to schedule a visit to conduct the software update to your console on site. The visit will take approximately 30-45 minutes. Our goal for the completion of updates for all existing customers is by August 31st. Actions to be taken by the Customer: 1) If you drop or have dropped your handpiece, stop immediate use of the handpiece and contact Cytrellis. 2) Complete the attached Recall Return Response Form and provide it to the service engineering representative that conducts the software update on the device located at your site as acknowledgment of this recall. Any questions can be directed to medicalinformation@cytrellis.com. Website: www.cytrellis.com
Quantity in Commerce127 systems
DistributionNationwide
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QAI
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