PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 31, 2018 Initiated: December 13, 2017 #Z-0409-2018

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.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
N/A
Distribution
Worldwide
Location
Memphis, TN

Frequently Asked Questions

What product 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.. Recalled by Smith & Nephew, Inc.. Units affected: N/A.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 31, 2018. Severity: Moderate. Recall number: Z-0409-2018.