VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit — Class II medical device recall Z-2100-2018
Terminated recall by VGI Medical, LLC, reported 2018-06-13, distributed in FL, MI, NY. IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
| Recall number | Z-2100-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VGI Medical, LLC, Seminole, FL, United States |
| Recall initiated | 2018-04-09 |
| Classified | 2018-06-05 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-08-21 |
| Distributed | FL, MI, NY |
| Quantity | 6 units |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2100-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.