INHANCE 6200-30-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295539100), received between Oct 18, 2022 and Sep 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874733 ↗
• MalfunctionJul 2, 2026Crack

  IT WAS REPORTED THAT DURING STERILE PROCESSING, THE INSTRUMENT WAS FOUND TO BE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691904 ↗
• MalfunctionFeb 17, 2026Crack

  IT WAS REPORTED BY THE STERILE PROCESSING TECH THAT THERE WAS A CRACK FOUND IN THE SMALL HUMERAL SIZER AFTER THE SURGERY AND THEY WOULD NOT PUT THE TRAY BACK UP UNTIL THIS SIZER WAS REPLACED. THIS HAPPENED POST OP, SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT, NOR WAS SURGERY TIME EXTENDED DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366649 ↗
• MalfunctionJan 20, 2026Crack

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SMALL HUMERAL SIZER WAS CRACKED. THE THREAD ON THE CONVEX IMPACTOR TIP WAS STRIPPED OUT AND IT WAS NOT ENGAGING THE IMPACTOR HANDLE. BOTH PARTS NEED TO BE REPLACED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ALL PARTS WERE RETRIEVED. NOTHING WAS LEFT ON FIELD OR IN PATIENT. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115505 ↗
• MalfunctionDec 17, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE OPENING OF THE HUMERAL SIZER HANDLE WAS CRACKED, PREVENTING THE HANDLE FROM REMAINING CONNECTED TO THE HUMERAL SIZER TRIAL. THE SURGERY BEING PERFORMED WAS A TOTAL SHOULDER REPLACEMENT. NO PIECES CRACKED OFF. IT WAS FURTHER REPORTED THAT WHILE PLACING THE VERSION GUIDE ONTO THE STEM INSERTER, THE CLIP CRACKED AND WOULD NOT REMAIN CONNECTED TO THE STEM INSERTER; AGAIN, NO PIECES CRACKED OFF, NO PATIENT HARM, AND NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829426 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT THE PIECE WAS BROKEN UPON ASSEMBLY. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038956 ↗
• MalfunctionJul 29, 2025Crack; Crack

  IT WAS REPORTED THAT THE SIZERS WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652982 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT THE SILHOUETTE RESECTION GUIDE PIN BECAME CROSS THREADED. THE SMALL HUMERAL DISC SIZER BROKE IN HALF. THIS DID NOT AFFECT THE SURGERY. THE SURGERY WAS NOT DELAYED AND NO ADVERSE AFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087106 ↗
• MalfunctionDec 7, 2023Scratched Material; Scratched Material

  HUMERAL SIZERS ARE SCUFFED, STAFF WILL NOT REPROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281901 ↗
• MalfunctionNov 7, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE HUMERAL SIZER IS SCUFFED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745641 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE DURING SURGERY, NO PIECES WERE LEFT IN PATIENT. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625485 ↗