Events

Recall of Device Recall Taylor Spatial Frame Website software

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
    78840
  • Event Risk Class
    Class 2
  • Event Number
    Z-0409-2018
  • Event Initiated Date
    2017-12-13
  • Event Date Posted
    2018-01-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160710
  • 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
    Software for diagnosis/treatment - Product Code OSN
  • Reason
    In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. the frame will appear inverted in the preview images on the strut settings tab.
  • Action
    The firm initiated their recall by email on 12/13/2017. Users are asked if they notice an inverted frame in the software to repeat the process for the same case and notify a Smith & Nephew representative. In addition, they are asked to double check plannings for strut adjustments and compare with the images printed as described above.

Device

Device Recall Taylor Spatial Frame Website software
  • Model / Serial
    Version 5.2.5 and 5.2.6
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA