Recall Z-0879-2017 ยท HSB Rod, Fixation, Intramedullary And Accessories
OrthoPediatrics Corp
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
| Date | Dec 22, 2016 (initiated Nov 18, 2016) |
| Status | Terminated |
| Reason | Labeled as a 48mm Cortical Screw but measuring at 50mm |
| Root cause | Labeling mix-ups |
| Action | OrthoPediatrics sent an URGENT MEDICAL DEVICE RECALL notification on November 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. . It is important that you carefully follow these recall instructions: " Please immediately take possession of any of these screws your customer may have or that you have, and quarantine them. Contact logistics@orthopediatrics.com to receive a Return Authorization Number. It is very important that we contain these devices rapidly and maintain them in quarantine. Replacement device |
| Quantity | 22 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM OrthoPediatrics Corp., Mar 11, 2009 |