Z-2100-2018Class II

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

Name: Z-2100-2018 VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Creator: VGI Medical, LLC
Published: 2018-04-09
License: https://open.fda.gov/license/

VGI medical, LLC / initiated 2018-04-09 / Terminated / root cause: manufacturing process

FDA source

VGI Medical, LLC began a recall of VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit on 2018-04-09. FDA classified it as Class II and gives the reason as "IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2100-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-09
Posted: 2018-06-05
Terminated: 2020-08-21
Recalling firm: VGI medical, LLC
Product: VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 6 units
Distribution: Distributed to MI, FL, and NY.
Product codes and lots: Lots of Instrument Sets: LP-INSTSET-001, VLP-INSTSET-002, VLP-INSTSET-003, VLP-INSTSET-004, VLP-INSTSET-005, VLP-INSTSET-006. Lots of individual instruments contained in sets: 127617, 127901, 127902, 127903, 127904, 127905, 127906, 127907, 127908, 133003, 133004, 133005, 1330-1, 1330-2, 1330-6, 133004, 1285001, 144301, 144302, 163214, 1401001, 157801, 162402 163203, 163204, 163205, 163206, 163207, 163208, 163209, 163212, 163213, and 163214.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-05

Product code OVD

K151312Class IIVerteLP Interbody Fusion DeviceVgi, LLC / cleared 2016-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)