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Lower risk Medical device recall · FDA · Published December 13, 2017

Smith & Nephew Taylor Spatial Frame Software Recalled: Inverted Frame Preview Risk

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.

🇺🇸 FDA recall #Z-0409-2018Medical deviceSmith & Nephew ›
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Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/72332-smith-nephew-taylor-spatial-frame-software-recalled-inverted-frame-preview.

Source Summary by GovInfoNow · govinfonow.com/recall/72332-smith-nephew-taylor-spatial-frame-software-recalled-inverted-frame-preview · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0409-2018

Cite this page

“Smith & Nephew Taylor Spatial Frame Software Recalled: Inverted Frame Preview Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72332-smith-nephew-taylor-spatial-frame-software-recalled-inverted-frame-preview. Based on FDA recall #Z-0409-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0409-2018%22&limit=1).

The FDA announced on Dec. 13, 2017, that Smith & Nephew, Inc. is recalling its Taylor Spatial Frame Website software, catalog number 71070401, versions 5.2.5 and 5.2.6. The agency stated the recall addresses a hazard where the software may generate an inverted image of the frame during surgical planning.

How to tell if you have it

  • Smith & Nephew Taylor Spatial Frame Website software
  • Catalog Number 71070401
  • Versions 5.2.5 and 5.2.6

The hazard

According to the FDA, when surgeons use the software to plan strut adjustments, an inverted image of the frame is generated. This results in the frame appearing inverted in the preview images on the Strut Settings tab.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls since July 24, 2017. Recent brand recalls include a TRIGEN Humeral Nail recall on March 16, 2026, and a BIOSURE HA Screw recall on Nov. 24, 2025. Other recent recalls of similar products include the Siemens LUMINOS Q.namix R X-Ray System recall (Dec. 29, 2025) and the Staar ICL Software Version 8.00 recall (April 20, 2026).

How to tell if you have this one

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.

  • Brand
    Smith & Nephew
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your software version by looking for version numbers 5.2.5 or 5.2.6 in the application settings.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

1. Firm started the recall: Dec 13, 201712. FDA classified it Class II: Jan 24, 201823. Published in FDA’s Enforcement Report: Jan 31, 201834. FDA terminated the recall: Oct 5, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have the recalled software?

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.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0409-2018 (December 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0409-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA