Events

Recall of 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM

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
    66450
  • Event Risk Class
    Class 2
  • Event Number
    Z-0276-2014
  • Event Date Posted
    2013-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122418
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    The firm identified, through complaints that the 3.5mm locking screw packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. upon investigation, it has been determined that a lot number 009u2 was packaged and mislabeled internally by orthopediatrics.
  • Action
    OrthoPediatrics sent an Urgent Medical Device Recall letter dated September 26, 2013, to all affected customers.The letter identified the product the problem and the actions needed to be taken by the customer The sales representatives and distributors who have been identified via shipping records as having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on 18-September-2013. If you or any of your customers have any of these devices in the original packaging please take possession of them and quarantine them in preparation for returning them to OrthoPedlatrics. They are misbranded. If the Screw has already been removed from the original packaging and the original packaging has been discarded and the Screw placed in a sterilization tray, it need not be returned. For further questions please call ( 574) 268-6379.

Device

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM
  • Model / Serial
    Part Number:. 00-0903-2634 and lot number 009U2
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
  • Product Description
    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM || The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • Manufacturer Address
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Manufacturer Parent Company (2017)
    Orthopediatrics Corp
  • Source
    USFDA