GAMMA 8325-2240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327593884), received between Dec 23, 2025 and Apr 21, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Positioning Failure; Malposition of Device

  AS REPORTED: "MISTARGETING OCCURRED AT THE MOST DISTAL HOLE OF THE INTERMEDIATE NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938549 ↗
• MalfunctionMar 23, 2026Malposition of Device

  AS REPORTED: "WHEN USING THE LAG SCREW DRILL, THERE WAS SLIGHT RESISTANCE, AND WHEN REMOVING THE DRILL BIT, A METAL-LIKE FRAGMENT WAS ADHERING TO IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661195 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE NAIL WAS IMPLANTED ON 2025. (B)(6) 2025, REVISION SURGERY IS SCHEDULED ON (B)(6) 2025, SINCE THE DISTAL BONE FRAGMENT WAS JOINED IN AN INTERNALLY ROTATED POSITION. AS REVISION SURGERY FOR THE ARTIFICIAL HIP JOINT (NOT STRYKER PRODUCT) BECAME NECESSARY, REVISION SURGERY WILL BE PERFORMED AT THE SAME TIME."

  Patient problems: Malunion of Bone

  MAUDE report 23875437 ↗