OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-094Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132119235), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

27 other recalls cover devices cleared under the same FDA submission (K083726); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2020Fracture; Fracture

  DURING A SCHEDULED HARDWARE REMOVAL, THE IM FEMORAL NAIL FRACTURED WHEN THE SURGEON ATTEMPTED TO EXPLANT IT. NO ADVERSE PATIENT ISSUES WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083726. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2017 · Nov 18, 2016 · Terminated
  OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
• Z-0364-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-087. The system is used for pediatric and small stature adult patients
• Z-0342-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-024. The system is used for pediatric and small stature adult patients
• Z-0360-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-083. The system is used for pediatric and small stature adult patients
• Z-0339-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-021. The system is used for pediatric and small stature adult patients
• Z-0356-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-075. The system is used for pediatric and small stature adult patients
• Z-0362-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-085. The system is used for pediatric and small stature adult patients
• Z-0351-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-037. The system is used for pediatric and small stature adult patients
• Z-0359-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-082. The system is used for pediatric and small stature adult patients
• Z-0347-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-033. The system is used for pediatric and small stature adult patients
• Z-0343-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-025. The system is used for pediatric and small stature adult patients to s
• Z-0344-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-026. The system is used for pediatric and small stature adult patients
• Z-0346-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-032. The system is used for pediatric and small stature adult patients
• Z-0345-2010 · Jul 21, 2009 · Terminated
  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
• Z-0352-2010 · Jul 21, 2009 · Terminated
  Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-071. The system is used for pediatric and small stature adult patients

…and 12 more.