Class II — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. |
| Product | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc® Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc® system. The PediLoc® Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc® Extension Osteotomy Plate is designed to fit … |
| Quantity | 24 |
| Distribution | Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX. |
| Initiated | 2012-10-18 |
| Classified | 2012-11-22 |
| Terminated | 2013-09-18 |
| Recall number | Z-0432-2013 |
| 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-0432-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63554/
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