INHANCE 6200-48-195Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295539247), received between Jan 10, 2023 and Aug 31, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523565 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE 5 REVERSE HUMERAL TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087252 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE 5 REVERSE HUMERAL TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086941 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT 5 BROKEN REVERSE HUMERAL TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066592 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT 5 BROKEN REVERSE HUMERAL TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058998 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS DISCOVERED DURING THE CASE ON (B)(6) 2024 THAT THE FINS INSIDE THE ANATOMIC HEAD TRIAL WERE BROKEN. IT WAS ALSO DISCOVERED DURING THE CASE THAT THE XS GLENOID TRIAL WAS MARRED UP AND DAMAGED DURING THE CASE. THE PIECES WERE TOSSED PRIOR TO OBTAINING A LOT NUMBER. NO PIECES WERE LEFT BEHIND IN THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521429 ↗
• MalfunctionApr 16, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: THE PLASTIC PEGS INSIDE THE INHANCE HUMERAL HEAD TRIAL BROKE OFF, AND ALL PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121449 ↗
• MalfunctionFeb 13, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED. A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT, BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. B. DID THE EVENT OCCUR, DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. C. WERE THERE PIECES BROKEN OFF FROM THE INSTRUMENT? IF YES, DID IT BREAK INTO 2 OR MORE PIECES? NO PIECES BROKEN OFF. D. WHAT PART OF THE INSTRUMENTS WERE BROKEN? HUMERAL HEAD TRIALS BROKE ON THE INSIDE WHERE ADAPTER TRIAL FITS. VERSION INDICATOR PLASTIC PART CRACKED, SIZER AND GLENOID TRIALS CRACKED, INSERTER TIP THREADS WORN. E. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693913 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT HEAD TRIALS BROKE WHILE DISENGAGING/ENGAGING OFFSET ADAPTER. THERE WAS 10 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16132409 ↗