Smith & Nephew, Inc. recalls Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application softw…

Recall date

December 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0409-2018

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.