Events

Recall of Trochar Scalpel Instrument (Surgical Punch)

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
    63396
  • Event Risk Class
    Class 2
  • Event Number
    Z-0207-2013
  • Event Initiated Date
    2012-09-13
  • Event Date Posted
    2012-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113679
  • 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
    Mixture, hematology quality control - Product Code HSB
  • Reason
    A complaint received from sales representative that a replenishment instrument was too short. upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
  • Action
    OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.

Device

Trochar Scalpel Instrument (Surgical Punch)
  • Model / Serial
    Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
  • Product Description
    Trochar Scalpel Instrument (Surgical Punch) || OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
  • 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