Class III — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Labeled as a 48mm Cortical Screw but measuring at 50mm |
| Product | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw |
| Quantity | 22 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland. |
| Initiated | 2016-11-18 |
| Classified | 2016-12-22 |
| Terminated | 2017-07-27 |
| Recall number | Z-0879-2017 |
| 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 III recall — OrthoPediatrics Corp (Z-0879-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75758/
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