medical Class II Updated 2018-06-13

VGI Medical, LLC recalls VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

Recalled Product

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit


Hazard / Issue

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

Issued by

FDA

Affected States: MI, FL, NY
Lot/Code Info: 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.
View official government recall

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