Events

Recall of Device Recall OrthoPediatrics PediLoc Locking 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
    65828
  • Event Risk Class
    Class 2
  • Event Number
    Z-1941-2013
  • Event Initiated Date
    2013-07-24
  • Event Date Posted
    2013-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120334
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Orthopediatrics has initiated a voluntary recall of part # 01-1050-002, 2.5mm drill bit, lot #91300335. only drill bits that are in their original packaging are being recalled. the description on the package of this drill bit has a wrong size in the description (3.2mm). the recall affects only packaged devices still in original packaging due to misbranding of the product. the drill bit itself has.
  • Action
    On 7/24/13, OrthoPediatrics notified their consignees of this URGENT MEDICAL DEVICE RECALL via phone call. A follow-up email message was then sent with the recall notification, and then a hard copy of the notice was sent via certified letter. The notification addresses the affected product, recall issue, reply form instructions, and directs consignees to return affected product to OrthoPediatrics via a Fed-Ex return prepaid pouch. The firm directs consignees to forward the notification and reply form if the product was further distributed.

Device

Device Recall OrthoPediatrics PediLoc Locking Plate System
  • Model / Serial
    LOT 91300335 - Catalogue Number 01-1050-0002
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
  • Product Description
    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
  • 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