Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Summary
The FDA issued a Class II for Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal by Vivorte, Inc.. Reason: incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018.
Details
Source
Device Recall
External ID
Z-2024-2021
Action Date
2021-07-14
Status
Terminated
Category
device
Product Description
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Lot/Code Info: 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.
Quantity Affected: 12 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2018-09-09
Company
Louisville, KY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vivorte, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vivorte, Inc. have FDA actions?
This is the only FDA action we have on record for Vivorte, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2024-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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