Class 2 Device Recall Orthopediatrics IM Femoral Nail

• Date Initiated by Firm: July 21, 2009
• Date Posted: May 12, 2010
• Recall Status: Terminated on October 25, 2010
• Recall Number: Z-0355-2010
• Recall Event ID: 52852
• 510(K)Number: K083726
• Product Classification: Nail - Product Code HSB
• Product: Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-074. 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
• Code Information: Lots 105419 and 105420.
• Recalling Firm/ Manufacturer: Orthopediatrics Corp; 210 N Buffalo St; Warsaw IN 46580-2730
• For Additional Information Contact: 574-268-6379
• Manufacturer Reason for Recall: The potential exists for the nails to fracture during insertion of the nail.
• FDA Determined 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 in Commerce: 23 of all products
• Distribution: Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HSB