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 | There is a material mislabeling of the AFN End Cap. |
| Product | Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail. |
| Quantity | 277 units |
| Distribution | US distribution to MD, NY & PA |
| Initiated | 2017-04-19 |
| Classified | 2017-07-28 |
| Terminated | 2019-03-19 |
| Recall number | Z-2780-2017 |
| 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-2780-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77490/
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