FDA recall Z-2100-2018

Product

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

Distributed to MI, FL, and NY.

Key facts

Status

Terminated

Initiation date

2018-04-09

Report date

2018-06-13

Termination date

2020-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seminole, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2100-2018