FDAClass IIJuly 14, 2021

Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone recall

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

Why was Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Recalling firm
Vivorte, Inc.
Quantity
12 units
Distribution
US state of KY
Recall date
July 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls