The Recall Desk
HighFDA (Devices)·Z-0409-2018·Announced 2018-01-31

Smith & Nephew Taylor Spatial Frame Software Recalled for Image Inversion

Smith & Nephew is recalling Taylor Spatial Frame software versions 5.2.5 and 5.2.6 because the software may generate inverted images of the frame during strut adjustment planning.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software error that could lead to incorrect surgical planning, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Smith & Nephew, Inc. is recalling the Taylor Spatial Frame Website software, Catalog Number 71070401, versions 5.2.5 and 5.2.6. This software is a web-based and mobile application component of a multilateral external fixation system intended for fracture fixation, fixation of long bones, and joint fusions or limb lengthening. The recall is classified as Class II by the FDA.

The recall is issued because, in rare circumstances, the software may generate an inverted image of the frame when surgeons use it to plan strut adjustments. This inversion appears in the preview images on the Strut Settings tab. The software was distributed worldwide.

Surgeons and healthcare facilities using this software should stop using the affected versions and contact Smith & Nephew for instructions on how to proceed. No specific number of affected units or reported injuries is stated in the source text.

The recalled product

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 lengtheni
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Version 5.2.5 and 5.2.6

Distribution

Distribution scope not specified by the agency.

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