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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 Kitsee related information
Date Initiated by FirmApril 09, 2018
Create DateJune 05, 2018
Recall Status1 Terminated 3 on August 21, 2020
Recall NumberZ-2100-2018
Recall Event ID 80012
510(K)NumberK151312 
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
ProductVGI 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 ContactNancy 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
ActionThe 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 Commerce6 units
DistributionDistributed to MI, FL, and NY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OVD
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