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Terminated

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

FDA Recall Z-2024-2021 · Posted 2021-07-07

Recalling FirmVivorte, Inc.
Recall StatusTerminated
Product CodeMBP
Date Initiated2018-09-09
Date Terminated2021-11-17
Product Quantity12 units

Reason for Recall

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

Firm Action

Vivorte issued Medical Device Removal letter via email on 9/7/2018. Letter states reason for recall, health risk and action to be taken: We recommend that you take the following short-term actions: Ship any Trabexus EB lot MA-170727-01 back to Vivort, Inc. using the included product replacement form. Lot MA-170727-01 will be relabeled to be sent back to you upon request. Contact Therese Montano at [email protected] with further questions

Root Cause

Labeling Change Control

Distribution Pattern

US state of KY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130703VIVORTE BVFVivorte, Inc. · 2013-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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