Recall Z-2100-2018— VGI Medical, LLC

Name: FDA recall Z-2100-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-09

Class II · Terminated

Class II FDA medical device recall by VGI Medical, LLC, initiated 2018-04-09, terminated 2020-08-21. It names one FDA 510(k) clearance: K151312. Product: VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit. Reason: IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated.

Recalling firm: VGI Medical, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-04-09
Terminated: 2020-08-21
Firm location: Seminole, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K151312 — VerteLP Interbody Fusion DeviceVgi, LLC·cleared 2016-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.