Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88165

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Vivorte, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2024-2021
Recall number
Z-2024-2021
Initiated
September 09, 2018
Classification
Class II
Status
Terminated
Recalling firm
Vivorte, Inc.
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US state of KY

Field note

Send feedback

We'll only use this to respond to your feedback.