Z-1146-2020Class II

Revanesse Versa, PN40081

Name: Z-1146-2020 Revanesse Versa, PN40081
Creator: Prollenium Medical Technologies Inc.
Published: 2018-11-15
License: https://open.fda.gov/license/

Prollenium Medical Technologies Inc. / initiated 2018-11-15 / Terminated / root cause: labeling and UDI

FDA source

Prollenium Medical Technologies Inc. began a recall of Revanesse Versa, PN40081 on 2018-11-15. FDA classified it as Class II and gives the reason as "Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1146-2020
Classification: Class II
Status: Terminated
Initiated: 2018-11-15
Posted: 2020-02-11
Terminated: 2024-03-22
Recalling firm: Prollenium Medical Technologies Inc.
Product: Revanesse Versa, PN40081
Product code: LMH Implant, Dermal, For Aesthetic Use
Reason for recall: Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A 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 commerce: 48,457 kits
Distribution: US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-10

Product code LMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)