Class II — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. |
| Product | Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabili… |
| Quantity | 78 |
| Distribution | Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA. |
| Initiated | 2012-09-13 |
| Classified | 2012-11-05 |
| Terminated | 2013-09-18 |
| Recall number | Z-0207-2013 |
| 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-0207-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63396/
Alerts for ORTHOPEDIATRICS, CORP
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.