Class II — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. |
| Product | OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures. |
| Quantity | 15 devices |
| Distribution | Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia. |
| Initiated | 2012-06-14 |
| Classified | 2012-07-20 |
| Terminated | 2013-04-30 |
| Recall number | Z-2057-2012 |
| 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 — OrthoPediatrics Corp (Z-2057-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62351/
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