INHANCE 6200-30-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295539117), received between Nov 16, 2023 and Sep 23, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874740 ↗
• MalfunctionMar 9, 2026Crack

  IT WAS REPORTED THE HUMERAL SIZER CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547241 ↗
• MalfunctionJan 14, 2026Crack

  IT WAS REPORTED THAT THE PLASTIC MEDIUM HUMERAL SIZER CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066243 ↗
• MalfunctionAug 7, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 20 DRIVER IS STRIPPED. M AND L SIZERS ARE CRACKED AND WON'T ACCEPT SIZER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736687 ↗
• MalfunctionAug 7, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 20 DRIVER IS STRIPPED. M AND L SIZERS ARE CRACKED AND WON'T ACCEPT SIZER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736558 ↗
• MalfunctionJun 3, 2025Crack; Crack

  IT WAS REPORTED THAT THE HUMERAL SIZER WAS NOTICED TO BE CRACKED AND THE GLENOID INSERTER TIP IS STRIPPED AND WILL NOT THREAD IN TO THE HANDLE. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132697 ↗
• MalfunctionAug 22, 2024Crack; Crack

  IT WAS REPORTED THAT THESE ITEMS WERE CRACKED AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038869 ↗
• MalfunctionMar 12, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: THE DELAY WAS LIKELY IN THE AREA OF 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887371 ↗
• MalfunctionJan 4, 2024Crack; Crack

  THE SALES REP WAS PUTTING TOGETHER THE SETS WHEN THEY FINISHED THE CASE WHEN HE NOTICED A CRACK GOING THROUGH THE MEDIUM HUMERAL SIZER. IT WAS STILL IN (B)(4) PIECE, AND THIS HAPPENED POST OP THEREFORE 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 18443141 ↗
• MalfunctionDec 7, 2023Scratched Material; Scratched Material

  HUMERAL SIZERS ARE SCUFFED, STAFF WILL NOT REPROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281898 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT PRODUCT WAS CHIPPED AFTER USE AND WASH. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230269 ↗
• MalfunctionNov 16, 2023Crack; Illegible Information; Crack; Illegible Information

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE SIZER CRACKED IN THE MIDDLE. IT ALSO STATES IT DID NOT BREAK, JUST CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149901 ↗