FDA Device recall Z-0409-2018
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401 by Smith And Nephew, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0409-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-13 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Version 5.2.5 and 5.2.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0409-2018%22
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