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U.S. Department of Health and Human Services

Class 2 Device Recall Vivorte Trabexus EB

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 Class 2 Device Recall Vivorte Trabexus EBsee related information
Date Initiated by FirmSeptember 09, 2018
Date PostedJuly 07, 2021
Recall Status1 Terminated 3 on November 17, 2021
Recall NumberZ-2024-2021
Recall Event ID 88165
510(K)NumberK130703 K143547 
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
ProductVivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Code Information Lot Number: MA-170727-01  Donation Identification Number (DIN): W2292 14 141647 00 Serial Numbers: 093 through 105.   Human readable UDI (under QR code on label):   =/W4146EB0010T0475=W22921414164700=,000XXX=>019046=}017239&,100000000MA17072701  where XXX ranges from 093 through 105.      
FEI Number 3010642815
Recalling Firm/
Manufacturer		 Vivorte, Inc.
1044 E Chestnut St
Louisville KY 40204-6033
For Additional Information ContactSAME
502-714-7234
Manufacturer Reason
for Recall		incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
FDA Determined
Cause 2		Labeling Change Control
ActionVivorte issued Medical Device Removal letter via email on 9/7/2018. Letter states reason for recall, health risk and action to be taken: We recommend that you take the following short-term actions: Ship any Trabexus EB lot MA-170727-01 back to Vivort, Inc. using the included product replacement form. Lot MA-170727-01 will be relabeled to be sent back to you upon request. Contact Therese Montano at tmontano@vivorte.com with further questions
Quantity in Commerce12 units
DistributionUS state of KY
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.
510(K) Database510(K)s with Product Code = MBP
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