Smith & Nephew recalls software version 5.2.5/5.2.6 for rare inverted frame previews during surgical planning, potentially causing misalignment in bone fixation procedures.
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.
Smith & Nephew is recalling specific software versions for their Taylor Spatial Frame system. In rare cases, the software may show an inverted frame preview during surgical planning, which could lead to improper bone alignment if used without correction.
The software occasionally generates inverted images of the frame during the strut adjustment preview. This could cause surgeons to misalign bones during procedures if they rely on the inverted preview without noticing the inversion.
Surgeons using Smith & Nephew Taylor Spatial Frame software versions 5.2.5 or 5.2.6 for bone fixation procedures are affected. Those performing surgical planning with this software are most at risk.
Check if you have the Smith & Nephew Taylor Spatial Frame software version 5.2.5 or 5.2.6. This software is part of a bone fixation system used for fractures and joint fusions.
Verify your software version by looking for version numbers 5.2.5 or 5.2.6 in the application settings.
The software may occasionally show an inverted frame preview during surgical planning, but this is rare and does not cause immediate harm. Surgeons should verify the frame orientation before proceeding.
The recalled software versions are 5.2.5 and 5.2.6. Check your application settings for these specific version numbers.
You can check your software version to see if it's affected. If it is, you may need to update to a newer version or contact Smith & Nephew for further guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0409-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0409-2018 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
