SIGMA 9505-02-807Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295229353), received between Jan 29, 2019 and Dec 19, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 9493409 ↗
• 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 9493404 ↗
• 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 9260772 ↗
• 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 9260718 ↗
• 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 9260691 ↗
• 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 9260641 ↗
• MalfunctionJan 29, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE INSTRUMENT TRAY IS FLAKING APART. PLASTIC SHIELDING IN TRAY IS FLAKING OFF OF THE METAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286101 ↗