INHANCE 6200-10-036Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL REAMER MEDIUM DIAMETER 36mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295539018), received between Mar 31, 2025 and Sep 11, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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
- Material Deformation2
- Device-Device Incompatibility1
- Illegible Information1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Device-Device Incompatibility; Illegible Information
It was reported that it did not happen in surgery. The medium reamer would not fit snugly or hold the reamer shaft anymore.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736994 ↗MalfunctionMar 31, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE REAMER WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21733165 ↗MalfunctionMar 31, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE REAMER WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21733157 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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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