OrthoPediatrics PediNail Intramedullary Nailing System 4 — Class III medical device recall Z-0879-2017
Terminated recall by OrthoPediatrics Corp, reported 2016-12-28, distributed in AZ, FL, GA, MO, NC, NY, TX. Labeled as a 48mm Cortical Screw but measuring at 50mm
| Recall number | Z-0879-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2016-11-18 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-07-27 |
| Distributed | AZ, FL, GA, MO, NC, NY, TX |
| Countries outside the US | FR, IE |
| Quantity | 22 units |
| Reason classes | labeling |
| Lot numbers | 161421-G |
Product
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Reason for recall
Labeled as a 48mm Cortical Screw but measuring at 50mm
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0879-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.