FDA Device recall Z-0879-2017
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
- FDA Device
- Class III
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class III recall of OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw by Orthopediatrics, citing labeled as a 48mm Cortical Screw but measuring at 50mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0879-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-11-18 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthopediatrics |
| Distribution | AZ, FL, GA, MO, NC, NY, TX |
Product
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Reason
Labeled as a 48mm Cortical Screw but measuring at 50mm
Identifiers
| code_info | Product Number: 10-1500-3048 Lot Number: 161421-G |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2017%22
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