Device 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.
Z-0409-2018
Product summary
- Event
- Event 78840
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0409-2018
Official wording
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.
Code information: Version 5.2.5 and 5.2.6
Distribution pattern: Worldwide
Derived failure modes
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Device software or design
software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will