Class II — restor3d Inc.
| Recalling firm | restor3d, inc. |
|---|---|
| Registered facility | restor3d, inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. |
| Product | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL. |
| Initiated | 2022-03-30 |
| Classified | 2022-04-29 |
| Terminated | 2023-08-28 |
| Recall number | Z-1027-2022 |
| 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 — restor3d Inc. (Z-1027-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89983/
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