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Terminated

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

FDA Recall Z-2100-2018 · Posted None

Recalling FirmVGI Medical, LLC
Recall StatusTerminated
Product CodeOVD
Date Initiated2018-04-09
Date Terminated2020-08-21
Product Quantity6 units

Reason for Recall

IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

Firm Action

The firm notified their direct consignees by letter on 04/09/2018 and followed with an e-mail on 04/11/2018. The letter directed the direct consignees (distributors) to instruct their accounts (user) to discontinue the automated cleaning process and to provide users with the new IFUs.

Root Cause

Process design

Distribution Pattern

Distributed to MI, FL, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151312VerteLP Interbody Fusion DeviceVgi, LLC · 2016-01-13

Official Source

View FDA Recall →

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

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