Home / Recalls / VGI Medical, LLC / Z-2100-2018

Z-2100-2018 Class II Terminated

Recalled by VGI Medical, LLC — Seminole, FL

Recall Details

Product Type
Devices
Report Date
June 13, 2018
Initiation Date
April 9, 2018
Termination Date
August 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

Reason for Recall

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

Distribution Pattern

Distributed to MI, FL, and NY.

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.