Events

Recall of Oxford/Oxbridge AFN End Cap

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

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
    77490
  • Event Risk Class
    Class 2
  • Event Number
    Z-2780-2017
  • Event Initiated Date
    2017-04-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156128
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    There is a material mislabeling of the afn end cap.
  • Action
    Orthosol notified their customers on 4/19/2017 via USPS.

Device

Oxford/Oxbridge AFN End Cap
  • Model / Serial
    Item Code OS331107  S1009023 Mar-2017 S1009023 Mar-2017  Item Code OS331104 S1009020 Apr-2017  Item Code OS331100 995035 Aug-2017; Jan-2018  Item Code  OS331100 S1212114 May-2018  Item Code OS331101 S1009017 Jun-2018  Item Code OS331103 S1009019 Oct-2018  Item Code OS331105 S1102004 Oct-2018  Item Code OS331100 S1307176 Nov-2018, Dec-2018 S1401116 Apr-2019  Item Code OS331103 S1009019 May-2019  Item Code OS331105 S1102004 May-2019  Item Code OOS331100 7802 Oct-2019
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution to MD, NY & PA
  • Product Description
    Oxford/Oxbridge AFN End Cap || 10 mm x 5 mm tp 12 mm x10 mm || The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
  • Manufacturer
    Ortho Solutions Inc

Manufacturer

Ortho Solutions Inc
  • Manufacturer Address
    Ortho Solutions Inc, 330 Franklin Tpke, Mahwah NJ 07430-3524
  • Manufacturer Parent Company (2017)
    Ortho Solutions Inc.
  • Source
    USFDA