Events

Recall of TRIGEN SURESHOT Distal Targeting System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew Inc.

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
    57047
  • Event Risk Class
    Class 2
  • Event Number
    Z-0411-2011
  • Event Initiated Date
    2010-10-15
  • Event Date Posted
    2010-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95238
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    Targeting software has been found to provide erroneous targeting when used with the 13 mm tan/fan left nails.
  • Action
    Smith & Nephew Inc. sent an URGENT MEDICAL DEVICE CORRECTION letter by FedEx on October 15, 2010, to all customers. The letter was dated October 4, 2010, and identified the product, the problem, and the action to be taken by the customers. Customers were instructed to perform a software upgrade and complete the form provided and return by fax to (901) 566-7835. For questions regarding this recall call (901) 399-5441.

Device

TRIGEN SURESHOT Distal Targeting System
  • Model / Serial
    All serial numbers prior to and including ACA5
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.
  • Product Description
    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 || Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA