Recall Z-0345-2010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-031. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been
| Date | May 12, 2010 (initiated Jul 21, 2009) |
| Status | Terminated |
| Reason | The potential exists for the nails to fracture during insertion of the nail. |
| Root cause | Device Design |
| Action | Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379. |
| Quantity | 23 of all products |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM OrthoPediatrics Corp., Mar 11, 2009 |