Recall Z-2024-2021— Vivorte, Inc.

Name: FDA recall Z-2024-2021
Creator: U.S. Food and Drug Administration
Published: 2018-09-09

Class II · Terminated

Class II FDA medical device recall by Vivorte, Inc., initiated 2018-09-09, terminated 2021-11-17. It names 2 FDA 510(k) clearances: K143547, K130703. Product: Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10. Reason: incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018.

Recalling firm: Vivorte, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-09
Terminated: 2021-11-17
Firm location: Louisville, KY, United States

510(k) clearances named in this recall

2 on FDA's record

K143547 — Vivorte Trabexus EBVivorte, Inc.·cleared 2015-01-14
K130703 — VIVORTE BVFVivorte, Inc.·cleared 2013-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018

Data sourced from openFDA. This site is unofficial and independent of the FDA.