GLOBAL CAP 2230-81-080Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL CAP HUMERAL HEAD SHAPER 52mm x 21mm · Class 1
All models of GLOBAL CAP (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295105077), received between Aug 5, 2019 and Oct 3, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.
Most reported problems
Device problems
- Material Twisted/Bent2
- Break1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE SHAPERS WERE BROKEN DUE TO USAGE. THEY WERE WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9152056 ↗MalfunctionAug 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
GLOBAL CAP REAMERS NOT WORKING - LOCKING MECHANISM WAS DISENGAGING WHEN PRESSURE IS APPLIED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES. IF YES, NUMBER OF MINUTES: --> 30. ACTION TAKEN WHEN EVENT OCCURRED? --> TRIED TO LOCK MECHANISM ONCE AGAIN DENTAL BURR WAS USED TO ACHIEVE SIMILAR RESULT AS REAMER. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.
Patient problems: Not Applicable
MAUDE report 8862000 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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