INHANCE 6105-10-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295538813), received between Aug 27, 2024 and Feb 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 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.

• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGICAL PROCEDURE, BOTH THE XS AND THE S GLENOID SIZERS WERE DAMAGED. THEY WERE NOT STAYING ATTACHED TO THE SIZER HANDLE. THERE WERE NO DELAYS OR ADVERSE EVENTS. ALL PARTS WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300663 ↗
• MalfunctionSep 5, 2025Crack; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF REASSEMBLY OF THE TRAY AFTER THE PROCEDURE, IT WAS NOTICED THAT 2 GLENOID INSERTER TIP HAVE BEEN CROSS THREADED. THE THREADS ARE DAMAGED AND WILL NOT GO ONTO THE INSERTION HANDLE SMOOTHLY. IT WAS ALSO NOTED THAT THE X SMALL ANATOMIC GLENOID SIZER WAS DAMAGED (CRACKED) AND IN NEED OF REPLACEMENT AND I WAS UNABLE TO MAKE OUT THE LOT NUMBER FOR THE X SMALL SIZER. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT; ALL BROKEN PIECES WHERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977747 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT WHEN PICKING UP TRAYS FROM CASES THAT WERE DONE THE PREVIOUS DAY, STAFF NOTICED THE TWO TRIAL INSTRUMENTS WERE BROKEN. THE PARTS NEEDED TO BE REPLACED TO GET THE SET BACK IN WORKING ORDER. NO DELAYS TOOK PLACE IN THE CASES. ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473169 ↗
• MalfunctionMar 24, 2025Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENTS CRACKED AND DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 21676181 ↗
• MalfunctionJan 29, 2025Crack; Crack

  IT WAS REPORTED THAT SIZER WAS CRACKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21264762 ↗
• MalfunctionJan 29, 2025Crack; Crack

  IT WAS REPORTED THAT SIZER WAS CRACKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21264760 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20075689 ↗