NA 164020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848486029777), received between Aug 31, 2022 and Dec 21, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Corroded; Contamination of Device Ingredient or Reagent; Corroded; Contamination of Device Ingredient or Reagent

  RETRACTOR HAS CUTS FROM BLADE. METAL SHAVING. RETRACTOR HAS MULTIPLE INDENTS FROM BLADE. METAL SHAVING. RUST IN RIO REGISTRATION TOOL. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023560 ↗
• MalfunctionSep 26, 2022Corroded; Contamination of Device Ingredient or Reagent; Corroded; Contamination of Device Ingredient or Reagent

  RUST FOUND IN BOTH REGISTRATION TOOLS CONTAMINATING A WHOLE BACK TABLE SETUP. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484261 ↗
• MalfunctionSep 22, 2022Corroded; Contamination of Device Ingredient or Reagent; Corroded; Contamination of Device Ingredient or Reagent

  RUST FOUND IN BOTH REGISTRATION TOOLS CONTAMINATING A WHOLE BACK TABLE SETUP. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463299 ↗
• MalfunctionAug 31, 2022Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  REGISTRATION TOOL HAS RUST IN OPENING. SPD HAS ATTEMPTED TO CLEAN BUT WAS NOT ABLE TO. FOR STERILITY PURPOSES, PART NEEDS TO BE REPLACED. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327220 ↗
• MalfunctionAug 31, 2022Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  REGISTRATION TOOL HAS RUST IN OPENING. SPD HAS ATTEMPTED TO CLEAN BUT WAS NOT ABLE TO. FOR STERILITY PURPOSES, PART NEEDS TO BE REPLACED. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327035 ↗