INHANCE 6200-30-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295539094), received between Jan 4, 2022 and Dec 4, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Crack; Crack

  IT WAS REPORTED THAT DURING ASSEMBLY OF THE INSTRUMENTS, IT WAS OBSERVED THAT THERE WAS A CRACK IN THE XS HUMERAL SIZE. IT WAS REPORTED THAT THE EVENT OCCURRED POST SURGERY SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716155 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN HUMERAL SIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632988 ↗
• MalfunctionJul 29, 2025Crack; Crack

  IT WAS REPORTED THAT THE SIZERS WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652845 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT CUTTING GUIDE WOULD NOT ACCEPT PINS AND SEEMS WARPED. XS HUMERAL SIZER BROKE, L AND XL GLENOID SIZER ALSO BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20571537 ↗
• MalfunctionAug 14, 2024Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS IT WAS NOTICED THAT MULTIPLE ITEMS ARE CRACKED/ HAVE WORN THREADS. THE EVENT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983622 ↗
• MalfunctionFeb 13, 2024Crack; Crack

  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 18693923 ↗
• MalfunctionFeb 12, 2024Incorrect Measurement; Incorrect Measurement

  ADDITIONAL INFORMATION WAS RECEIVED: NO SURGICAL DELAY . NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18688817 ↗
• MalfunctionJan 26, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY AND NO ADVERSE EFFECTS ON THE PATIENT. LOT NUMBERS WERE ALL NOT LEGIBLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587605 ↗
• MalfunctionDec 7, 2023Scratched Material; Scratched Material

  HUMERAL SIZERS ARE SCUFFED, STAFF WILL NOT REPROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281903 ↗
• MalfunctionMay 9, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SIZER IS SCUFFED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896222 ↗
• MalfunctionApr 27, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT ITEM WAS SCUFFED. WOULD NOT PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218234 ↗
• MalfunctionJan 4, 2022Break; Break

  CONCAVE IMPACTOR TIP IS STRIPED. HUMERAL SIZER XS IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151369 ↗