CLASS II Device recall · Reported 14 Jul 2021 · FDA Enforcement Report
Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect recalled
Vivorte is recalling Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system, distributed in Kentucky. The recall was initiated on 9 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2024-2021
- FDA event ID
- 88165
- Recalling firm
- Vivorte, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Sep 2018
- FDA classified
- 7 Jul 2021
- Reported
- 14 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 9 Sep 2018 | Recall initiated by company | |
| 7 Jul 2021 | Classified by FDA | +1032 days |
| 14 Jul 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Where it was distributed
US state of KY
Questions about this recall
Is Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system recalled?
Yes. Vivorte recalled Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system on 9 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-2024-2021.
Why was it recalled?
incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018
Which lots 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.
Where was it sold?
US state of KY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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