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U.S. Department of Health and Human Services

Class 2 Device Recall VerteLP Instrument Kit

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  Class 2 Device Recall VerteLP Instrument Kit see related information
Date Initiated by Firm April 09, 2018
Create Date June 05, 2018
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-2100-2018
Recall Event ID 80012
510(K)Number K151312  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
Product VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
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.
Recalling Firm/
Manufacturer		 VGI Medical, LLC
10401 Belcher Rd S
Seminole FL 33777-1415
For Additional Information Contact Nancy Adkins
727-565-1235
Manufacturer Reason
for Recall		 IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
FDA Determined
Cause 2		 Process design
Action The firm notified their direct consignees by letter on 04/09/2018 and followed with an e-mail on 04/11/2018. The letter directed the direct consignees (distributors) to instruct their accounts (user) to discontinue the automated cleaning process and to provide users with the new IFUs.
Quantity in Commerce 6 units
Distribution Distributed to MI, FL, and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OVD and Original Applicant = VGI, LLC
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