# FDA recall Z-0409-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2017-12-13.

## 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.

## 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.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0409-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-13
- **Report date:** 2018-01-31
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0409-2018

## Citation

> AI Analytics. FDA recall Z-0409-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0409-2018. Source: US FDA. Licensed CC0.

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