Hi-Fi 8536 (UDI 00810020085891)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810020085891), received between Jun 28, 2023 and Jun 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJun 28, 2023Unsealed Device Packaging; Unsealed Device Packaging

  ACCORDING TO THE REPORTER, "DURING MENISCUS REPAIR SURGERY, 8536 DOUBLE ARM NEEDLE WAS USED, AND SEVEN WERE USED FOR PATIENTS.TWO OF THEM WERE OPENED WITH PLASTIC PACKAGING AND PAPER BOXES OPENED TO USE THE PRODUCT, BUT THEY WERE NOT INCLUDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217163 ↗
• MalfunctionJun 28, 2023Unsealed Device Packaging; Unsealed Device Packaging

  ACCORDING TO THE REPORTER, "DURING MENISCUS REPAIR SURGERY, 8536 DOUBLE ARM NEEDLE WAS USED, AND SEVEN WERE USED FOR PATIENTS. TWO OF THEM WERE OPENED WITH PLASTIC PACKAGING AND PAPER BOXES OPENED TO USE THE PRODUCT, BUT THEY WERE NOT INCLUDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217051 ↗