VGI Medical, LLC: Medical Device Recall in 2018 - (Recall #: Z-2100-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

Product Classification:

Class II

Date Initiated: April 9, 2018

Date Posted: June 13, 2018

Recall Number: Z-2100-2018

Event ID: 80012

Reason for Recall:

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

Status: Terminated

Product Quantity: 6 units

Code Information:

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.

Distribution Pattern:

Distributed to MI, FL, and NY.

Voluntary or Mandated:

Voluntary: Firm initiated