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U.S. Department of Health and Human Services

Class 2 Device Recall Revanesse Versa

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 Class 2 Device Recall Revanesse Versasee related information
Date Initiated by FirmNovember 15, 2018
Create DateFebruary 11, 2020
Recall Status1 Terminated 3 on March 22, 2024
Recall NumberZ-1146-2020
Recall Event ID 83834
PMA NumberP160042 
Product Classification Implant, dermal, for aesthetic use - Product Code LMH
ProductRevanesse Versa, PN40081
Code Information Lot #/ Exp. date  17K004/July 31, 2018  17K005/July31,2018  I7K006/August 31, 2018  17K007/August 31, 2018  17K090/October 31, 2018  17K091/October 31, 2018  17L026/October 31, 2018  17L028/October 31, 2018  I7L050/November 30, 2018  17L0S1/November 30, 2018  18A023/November 30, 2018 18A024/November 30, 2018  I8E028/December 31, 2018  18E029/December 31, 2018  18F032/December 31, 2018  18F033/December 31, 2018  18G065/April 30, 2019  18G074/April 30, 2019  18G075/April 30, 2019  18G076/April 30, 2019  181022/June 30, 2019  181029/June 30, 2019  
FEI Number 3004423487
Recalling Firm/
Manufacturer		 Prollenium Medical Technologies Inc.
138 Industrial Pky N
Aurora Canada
For Additional Information ContactRene Van De zande
512-327-9997
Manufacturer Reason
for Recall		Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
FDA Determined
Cause 2		Other
ActionA letter containing the subject "Revanesse Versa Expiration Dating" was e-mail on Nov 15, 2018 and April 30, 2019 to all consignees. The letter informed consignees about the issue. The letter asked consignees to do the following: 1. We request you to verily if any Revanesse Versa kit lots listed in the table on Page 2 are in your possession, if so please set aside and do not use them if they are expired from their 12 month expiration date has passed. If you have any concerns with your existing Revanesse Versa kits, please ^ contact Prollenium with the information below. We will send you a shipping label that will allow you to send the product back to our distribution center. 2. Send email to info@prolIenium,com configured as follows: Business Name: XXX, Versa Lot #: XXX, Number of Expired Kits: XXX, Contact Person: XXX 3. Prollenium will inform you once the updated expiration date is approved by the US FDA.
Quantity in Commerce48,457 kits
DistributionUS Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
PMA DatabasePMAs with Product Code = LMH
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