FDA Device recall Z-2100-2018
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit by Vgi Medical, citing IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2100-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-09 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vgi Medical |
| Distribution | FL, MI, NY |
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
Identifiers
| code_info | Lots of Instrument Sets: LP-INSTSET-001, VLP-INSTSET-002, VLP-INSTSET-003, VLP-INSTSET-004, VLP-INSTSET-005, VLP-INSTSE…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2100-2018%22
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