Events

Recall of Device Recall Orthopediatrics PediLoc Tibial Plate System

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
    71933
  • Event Risk Class
    Class 2
  • Event Number
    Z-2796-2015
  • Event Initiated Date
    2015-07-28
  • Event Date Posted
    2015-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139558
  • 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 00-0903-2510, 3.5mm x 10mm non locking cortical screw, lot # 150192-j package may contain a different screw. the screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
  • Action
    OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.

Device

Device Recall Orthopediatrics PediLoc Tibial Plate System
  • Model / Serial
    Part number 00-0903-2510, Lot number 150192-J
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic: TN, IA Foreign: England VA/DOD: None
  • Product Description
    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System || Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
  • 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