VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument recall
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Why was VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument recalled?
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- Recalling firm
- VGI Medical, LLC
- Quantity
- 6 units
- Distribution
- Distributed to MI, FL, and NY.
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)