Events

Recall of Device Recall 3.5mm Bowed Locking Compression Femur Plates

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
    74928
  • Event Risk Class
    Class 2
  • Event Number
    Z-2844-2016
  • Event Initiated Date
    2016-07-27
  • Event Date Posted
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149115
  • 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 corp.Is voluntarily recalling multiple lots of the 3.5mm bowed locking compression femur 14-hole plate and 18-hole plate due to the devices being mislabeled.
  • Action
    Orthopediatrics initiated the recall of 3.5mm Bowed Locking Compression Femur Plates by distributing e-mails on 0July 27, 2016, followed by telephone calls to all customers on July 28, 2016. All distributors and direct representatives were sent an e-mail to provide them with a written notification of the voluntary recall and instruct them to quarantine all identified devices from the affected lot numbers immediately. Customers were instructed to quarantine recalled product and response via a hard copy Reply Form that was included in a hard copy of the Recall Notice. Each sales representative was also asked to contact Orthopediatrics Logistics Department to receive a Return Authorization Number for returning recalled product. in order to track their affected plates. If customers have any questions about this recall, they were instructed to reach out to the firm via phone (office: 574-267-0865) or email (acargill@orthopediatrics.com).

Device

Device Recall 3.5mm Bowed Locking Compression Femur Plates
  • Model / Serial
    Product Number: 00-1050-3218  Lot Number: NM02346
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
  • Product Description
    3.5mm Bowed Locking Compression Femur Plates, 18 hole || Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
  • 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