SPECIALIST 96-6335Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295247920), received between Jun 28, 2022 and Aug 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AT THE BEGINNING OF THE SURGERY, DAMAGE TO THE VARUS/VALGUS GUIDE WAS OBSERVED. IT DID NOT AFFECT THE SURGERY AT ANY TIME SINCE THE VARUS/VALGUS GUIDE WAS USED IN THE SAME WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451183 ↗
• MalfunctionJun 28, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INSTRUMENT IS LOOSE FROM AGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840570 ↗