Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and m...
FDA Recall #Z-0409-2018 — Class II — December 13, 2017
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.
Reason for Recall
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.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
Worldwide
Code Information
Version 5.2.5 and 5.2.6
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated