SIGMA 9505-02-801Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295229292), received between Mar 22, 2018 and Feb 7, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED ON THE BOX FOR TRAY 2, SEVERAL PLASTIC PARTS CAME OF THE BOX WHEN IT WAS WASHED AND THE NOTCH IMPACTOR IS WAY TO SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314353 ↗
• MalfunctionMar 21, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCOUNT COMPLAINT THAT THE HP SIGMA PANS WERE WORN OUT. ACCOUNT WAS REQUESTING TO REPLACE THESE WORN PANS BECAUSE ACCOUNT HAD A CONCERN ON THE FLAKING OF THE INTERIORS OF THE PAN TO POSSIBLY GET INTO WOUND OF PATIENT. THEREFORE ACCOUNT REQUESTED NEW PANS. SALES CONSULTANT WAS RETURNING THESE PANS FOR A CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840497 ↗
• MalfunctionMar 21, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCOUNT COMPLAINT THAT THE HP SIGMA PANS WERE WORN OUT. ACCOUNT WAS REQUESTING TO REPLACE THESE WORN PANS BECAUSE ACCOUNT HAD A CONCERN ON THE FLAKING OF THE INTERIORS OF THE PAN TO POSSIBLY GET INTO WOUND OF PATIENT. THEREFORE ACCOUNT REQUESTED NEW PANS. SALES CONSULTANT WAS RETURNING THESE PANS FOR A CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840496 ↗
• MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493407 ↗
• MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493389 ↗
• MalfunctionOct 31, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261156 ↗
• MalfunctionOct 31, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261153 ↗
• MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257637 ↗
• MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257635 ↗
• MalfunctionJun 24, 2019Corroded; Peeled/Delaminated; Material Deformation; Corroded; Peeled/Delaminated; Material Deformation

  THE CUSTOMER REPORTS THAT IT OCCURED A DETACHMENT OF THE TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8728424 ↗
• MalfunctionMar 22, 2018Delamination; Delamination

  IT WAS REPORTED THAT THE SIGMA TRAY WAS REPLACED DUE TO PEELING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363665 ↗