INHANCE 6200-30-044Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL SIZER X-LARGE diameter 44mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295539131), received between Jul 27, 2022 and Jul 11, 2025 — classified as 9 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.
Reports received per month
Most reported problems
Device problems
- Crack5
- Break3
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information3
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2025Break; Break
IT WAS REPORTED THAT THERE WAS BROKEN HUMERL DISC, STRIPPED IMPACTOR TIP AND STRIPPED STAR 20.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484578 ↗MalfunctionMar 19, 2025Crack; Crack
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPAIR SURGERY, AND THE HUMERAL SIZERS WERE CRACKED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21646376 ↗MalfunctionMar 19, 2025Crack; Crack
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPAIR SURGERY, AND THE HUMERAL SIZERS WERE CRACKED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21646369 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE PLASTIC COMPONENT BROKE.
Patient problems: Insufficient Information
MAUDE report 19081564 ↗MalfunctionFeb 23, 2024Crack; Crack
IT WAS REPORTED THAT THE HUMERAL AND GLENOID SIZER BOTH CRACKED. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773818 ↗MalfunctionDec 7, 2023Scratched Material; Scratched Material
HUMERAL SIZERS ARE SCUFFED, STAFF WILL NOT REPROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18281908 ↗MalfunctionNov 29, 2023Crack; Crack
IT WAS REPORTED THAT THE SIZER WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226731 ↗MalfunctionAug 23, 2023Crack; Crack
IT WAS REPORTED THAT THE XL HUMERAL SIZER IS CRACKED. NO SURGICAL DELAY .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17604484 ↗MalfunctionJul 27, 2022Break; Break
THE INHANCE EXTRA LARGE HUMERAL SIZING GUIDE SNAPPED DURING THE CASE, AND THE SHEATH AROUND THE INHANCE REAMER HANDLE BROKE DURING THE CASE. THE SIZER BROKE INTO 2 PIECES. THE TIP OF THE SHEATH OF THE REAMER HANDLE BROKE INTO MULTIPLE PIECES. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15114983 ↗
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- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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