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VISIONAIRE V0200128Recalls & reported problems

Smith & Nephew, Inc. · NONSTERILE VISIONAIRE UK MEDIAL GUIDE KIT · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556780039), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 26, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT, DURING A RIGHT MEDIAL SIDE UNI, A NS VIS UK MED KIT MALFUNCTIONED DUE TO THE PROXIMAL AND DISTAL CUTS BEING "TOO SHALLOW" AND THE IMPLANT SIZES TOO BIG. THIS ISSUE WAS SOLVED, AFTER A NON-SIGNIFICANT DELAY, BY SWITCHING TO A TKA PROCEDURE INSTEAD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15674665 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.