X-MESH 288900050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034222868), received between Aug 5, 2019 and May 16, 2025 — classified as 7 malfunctions.

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

• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038990 ↗
• MalfunctionMar 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING ROUTING TORQUE TESTING, THE TORQUE HANDLE IN QUESTION WAS FOUND TO BE OUT OF SPEC. THE TORQUE TESTED HIGHER THAN THE PRINT SPECIFICATION RANGE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN X-MESH EXPANDABLE CAGE SYSTEM TORQUE DRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836146 ↗
• MalfunctionMar 16, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TORQUE HANDLE WAS TESTED MULTIPLE TIMES AND EACH TIME IT SHOWED THAT IT WAS OUT OF TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE TORQUE DRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9834909 ↗
• MalfunctionJan 24, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TORQUE HANDLE WAS TESTED MULTIPLE TIMES AND IT SHOWED THAT IT WAS OUT OF TOLERANCE. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9629249 ↗
• MalfunctionSep 13, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AUGUST 22, 2019, THE X-MESH TORQUE DRIVER HANDLE WAS FOUND TO HAVE CALIBRATION FAILURE DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9034548 ↗
• MalfunctionAug 19, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907615 ↗
• MalfunctionAug 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE X-MESH TORQUE DRIVER HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 2.85-3.15. THE TORQUE TESTED HIGH ¿ 3.314-3.445. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8859850 ↗