Class II — VGI Medical, LLC
| Recalling firm | VGI Medical, LLC |
|---|---|
| Registered facility | VGI medical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated |
| Product | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit |
| Quantity | 6 units |
| Distribution | Distributed to MI, FL, and NY. |
| Initiated | 2018-04-09 |
| Classified | 2018-06-05 |
| Terminated | 2020-08-21 |
| Recall number | Z-2100-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — VGI Medical, LLC (Z-2100-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80012/
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