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Recall Observatory FDA recall evidence

Device product

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

Z-2024-2021

September 09, 2018

Class II

Product summary

Firm
Vivorte, Inc.
Event
Event 88165
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2024-2021

Official wording

Reason: 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

Derived failure modes

  • 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