Recall Z-0353-2010
Orthopediatrics Corp · initiated July 21, 2009
Product
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-072. 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 surgically prepared for correction of deformity
Codes / lots: Lots 105407 and 105408.
Reason for recall
The potential exists for the nails to fracture during insertion of the nail.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0353-2010
- Initiated
- July 21, 2009
- Posted by FDA
- May 12, 2010
- Terminated
- October 25, 2010
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 23 of all products
- Distribution
- Nationwide.
- Recalling firm
- Orthopediatrics Corp, Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0339-2010 | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0341-2010 | Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0342-2010 | Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0343-2010 | Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0344-2010 | Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0345-2010 | Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0346-2010 | Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0347-2010 | Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0348-2010 | Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0349-2010 | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0350-2010 | Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0351-2010 | Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0352-2010 | Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0354-2010 | Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0355-2010 | Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0356-2010 | Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0357-2010 | Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0358-2010 | Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0359-2010 | Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0360-2010 | Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0361-2010 | Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0362-2010 | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0363-2010 | Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |
| Z-0364-2010 | Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw…The potential exists for the nails to fracture during insertion of the nail. | 07/21/2009Terminated |