Class II — Ortho Solutions Inc
| Recalling firm | ORTHO SOLUTIONS INC |
|---|---|
| Registered facility | Ortho Solutions Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. |
| Product | FPS 35mm x 3.5 mm non-locking screw |
| Quantity | 15 |
| Distribution | US Distribution |
| Initiated | 2016-07-21 |
| Classified | 2016-09-16 |
| Terminated | 2016-10-12 |
| Recall number | Z-2835-2016 |
| 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 — Ortho Solutions Inc (Z-2835-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74849/
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