Device product
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Z-0879-2017
Product summary
- Event
- Event 75758
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22 units
- Official record key
device-enforcement:Z-0879-2017
Official wording
Reason: Labeled as a 48mm Cortical Screw but measuring at 50mm
Code information: Product Number: 10-1500-3048 Lot Number: 161421-G
Distribution pattern: Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
Derived failure modes
-
Unknown
Labeled as a 48mm Cortical Screw but measuring at 50mm