Events

Recall of Device Recall Orthopediatrics IM Femoral Nail

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthopediatrics Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52852
  • Event Risk Class
    Class 2
  • Event Number
    Z-0362-2010
  • Event Initiated Date
    2009-07-21
  • Event Date Posted
    2010-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84163
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Nail - Product Code HSB
  • Reason
    The potential exists for the nails to fracture during insertion of the nail.
  • 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.

Device

Device Recall Orthopediatrics IM Femoral Nail
  • Model / Serial
    Lots 105483 and 105484.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide.
  • Product Description
    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 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.
  • Manufacturer
    Orthopediatrics Corp

Manufacturer

Orthopediatrics Corp
  • Manufacturer Address
    Orthopediatrics Corp, 210 N Buffalo St, Warsaw IN 46580-2730
  • Manufacturer Parent Company (2017)
    Orthopediatrics Corp
  • Source
    USFDA