QUICKSET 2440-00-504Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295123743), received between Nov 13, 2020 and Jun 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionJun 10, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  CONSIGNMENT REPLACEMENT TRAYS REQUIRED DUE TO STERILISATION CONCERNS FOR PINNACLE TRIAL SHELLS, SCREW TRAY, X BACK GRATERS QUICKSET GRATERS AND SHELL TRIALS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176475 ↗
• MalfunctionJun 10, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  CONSIGNMENT REPLACEMENT TRAYS REQUIRED DUE TO STERILISATION CONCERNS FOR PINNACLE TRIAL SHELLS, SCREW TRAY, X BACK GRATERS QUICKSET GRATERS AND SHELL TRIALS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176453 ↗
• MalfunctionOct 3, 2023Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  THE DEVICE DAMAGED FOLLOWING THE CLEANING PROCESS AT THE FACILITY: THEY GOT RUSTED. AFTER SEVERAL CLEANINGS, THE RUST/DIRT ON THE PRODUCTS DOES NOT REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859794 ↗
• MalfunctionSep 8, 2023Break; Corroded; Contamination /Decontamination Problem; Break; Corroded; Contamination /Decontamination Problem

  THE PTA INSTRUMENT WAS RECEIVED AT THE CENTRAL STERILIZATION SERVICE, DURING THE TRACEABILITY PROCESS, IT WAS VERIFIED THAT THE STATUS OF THE TRAYS AND LID WAS ALREADY DETERIORATED: LID AND BROKEN TRAYS, WITH HOLES AND GLUE, OXIDIZED MILLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712561 ↗
• MalfunctionNov 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ALL THREE INNER TRAYS OF THE PINNACLE GREATER INSTRUMENT SET ARE STAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10839535 ↗