Events

Recall of Device Recall Piccolo Composite Tibia and Femoral Nailing Systems Ball Tip Guide Wire

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CarboFix Orthopedics, Ltd..

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
    74229
  • Event Risk Class
    Class 2
  • Event Number
    Z-1991-2016
  • Event Initiated Date
    2016-05-10
  • Event Date Posted
    2016-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146900
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Firm received complaints where the piccolo composite ball tip guide wire penetrated the internal package, and thus compromised the product sterility.
  • Action
    On May 10, 2016, an advisory notice was issued to all distributors that currently may possess (or supplied to hospital) the product. The notice was sent to a representative of the distributor companies via an e-mail (using confirm receipts for delivery and notification when the email is read), together with a letter to hospital(s) for the representative to use in case the distributor supplied the product to the hospital. The letter requested that the product be returned and also requested a sub-recall.

Device

Device Recall Piccolo Composite Tibia and Femoral Nailing Systems Ball Tip Guide Wire
  • Model / Serial
    Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
  • Product Description
    Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
  • Manufacturer
    CarboFix Orthopedics, Ltd.

Manufacturer

CarboFix Orthopedics, Ltd.
  • Manufacturer Address
    CarboFix Orthopedics, Ltd., 11 Ha, Hoslim St., Herzliya Israel
  • Source
    USFDA