Z-2024-2021Class II

Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10

Name: Z-2024-2021 Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Creator: Vivorte, Inc.
Published: 2018-09-09
License: https://open.fda.gov/license/

Vivorte, Inc. / initiated 2018-09-09 / Terminated / root cause: labeling and UDI

FDA source

Vivorte, Inc. began a recall of Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10 on 2018-09-09. FDA classified it as Class II and gives the reason as "incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018". 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-2024-2021
Classification: Class II
Status: Terminated
Initiated: 2018-09-09
Posted: 2021-07-07
Terminated: 2021-11-17
Recalling firm: Vivorte, Inc.
Product: Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Reason for recall: incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
Root cause tag: labeling and UDI
FDA root cause: 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 [email protected] with further questions
Quantity in commerce: 12 units
Distribution: US state of KY
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2024-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2024-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-07

Product code MBP

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)