FDA Medical Device Recalls (openFDA)
Vivorte, Inc.: Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
- Recall number
- Z-2024-2021
- 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
- Status
- Terminated
- Initiated
- 2018-09-09
- Posted
- 2021-07-07
- Terminated
- 2021-11-17
- Reason
- incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
- 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 tmontano@vivorte.com with further questions
- Quantity
- 12 units
- Distribution
- US state of KY
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K130703","K143547"]
- PMA numbers
- not on file
- Product code
- MBP
- Firm FEI
- 3010642815
- Firm city
- Louisville
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28