FDA recall Z-2024-2021

Vivorte, Inc. · Class II · device

Product

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

Distribution

US state of KY

Key facts

Status
Terminated
Initiation date
2018-09-09
Report date
2021-07-14
Termination date
2021-11-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2024-2021