Class II — ORTHO SOLUTIONS, LTD.
| Recalling firm | ORTHO SOLUTIONS INC |
|---|---|
| Registered facility | Ortho Solutions Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market. |
| Product | SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS. |
| Quantity | 120 |
| Distribution | U.S. |
| Initiated | 2017-10-10 |
| Classified | 2018-03-09 |
| Terminated | 2018-08-31 |
| Recall number | Z-0967-2018 |
| 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 — ORTHO SOLUTIONS, LTD. (Z-0967-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79218/
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