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Smith & Nephew, Inc. recalls Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application softw
Recalled January 31, 2018 · FDA recall Z-0409-2018 · Smith & Nephew
Hazard
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. · FDA Class II
Units
N/A
Sold at
Worldwide
Description
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.
Product
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(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →