Date Initiated by Firm |
September 09, 2018 |
Date Posted |
July 07, 2021 |
Recall Status1 |
Terminated 3 on November 17, 2021 |
Recall Number |
Z-2024-2021 |
Recall Event ID |
88165 |
510(K)Number |
K143547 K130703
|
Product Classification |
Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
|
Product |
Vivorte 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. |
Recalling Firm/ Manufacturer |
Vivorte, Inc. 1044 E Chestnut St Louisville KY 40204-6033
|
For Additional Information Contact |
SAME 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 |
Action |
Vivorte 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 Commerce |
12 units |
Distribution |
US state of KY |
Total Product Life Cycle |
TPLC Device Report
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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) Database |
510(K)s with Product Code = MBP and Original Applicant = VIVORTE, INC
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