MAGNIFUSE® Bone Graft 7509014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994986467), received between Jul 7, 2025 and Jul 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 31, 2023Class IIOpen, Classified

   The incorrect product labeling was applied to the product indicating the wrong size of product.

   Z-2524-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJul 7, 2025Nonstandard Device; Nonstandard Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING BONE GRAFTS. IT WAS REPORTED THAT THE PRODUCT (14X25 MAGNIFUSE) WAS OPENED AND PLACED ON THE STERILE FIELD LIKE NORMAL. THE SCRUB TECH NOTICED THAT THE PRODUCT WAS A LOT LARGER THAN NORMAL. IT WAS MEASURED AND DETERMINED TO BE NEARLY TWICE THE SIZE OF WHAT WAS NEEDED. THEREFORE, THE PRODUCT WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410554 ↗
• MalfunctionJul 7, 2025Nonstandard Device; Nonstandard Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING BONE GRAFTS. IT WAS REPORTED THAT THE PRODUCT (14X25 MAGNIFUSE) WAS OPENED AND PLACED ON THE STERILE FIELD LIKE NORMAL. THE SCRUB TECH NOTICED THAT THE PRODUCT WAS A LOT LARGER THAN NORMAL. IT WAS MEASURED AND DETERMINED TO BE NEARLY TWICE THE SIZE OF WHAT WAS NEEDED. THEREFORE, THE PRODUCT WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410536 ↗