DeRoyal 89-7483Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756741989), received between Feb 1, 2021 and Feb 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 2, 2021Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  A STERNUM SAW BLADE PACKAGED IN A CONVENIENCE KIT HAS A GREEN LABEL ON IT THAT SAYS "NON-STERILE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269472 ↗
• MalfunctionFeb 1, 2021Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  THE STERNUM SAW BLADE THAT IS PACKAGED INSIDE THE CONVENIENCE KIT HAD A LIME GREEN STICKER ON IT THAT SAID "NON-STERILE." THE SURGERY TEAM DID NOT USE THIS KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257716 ↗