GLOBAL ADVANTAGE 2128-62-150Recalls & reported problems
Depuy (Ireland) · GLOBAL ADVANTAGE + CUTTING GUIDE CLAMP · Class 1
All models of GLOBAL ADVANTAGE (28)
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 10603295089858), received between Apr 27, 2021 and Apr 19, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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.
Most reported problems
Device problems
- Mechanical Jam2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT AFTER CASE, NOTICED THIS INSTRUMENT WAS FAULTY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140951 ↗MalfunctionMay 14, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT WHEN SURGEON TRIED TO USE THE HUMERAL HEAD RESECTION GUIDE, THAT ADJUSTABLE PLUNGER INSTRUMENT WOULD NOT LET THE CUTTING GUIDE SLIDE TO THE APPROPRIATE POSITION, BECAUSE THE BALL-BEARING OR SPRING PIN INSIDE THE RESECTION WAS FROZEN. TRIED TO LOOSEN TO ALLOW ADJUSTMENT, BUT DID NOT SUCCEED. SURGEON PROCEEDED WITH THE SURGERY BY FREE-HANDING THE HUMERAL RESECTION. IT WAS ALSO REPORTED THAT ONLY ONE INSTRUMENT FAILED, THE CASE WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11828460 ↗MalfunctionApr 27, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THERE IS A BOLT IN THE QUICK CLAMP THAT IS STICKING OUT AND PREVENTING THE CUTTING GUIDE FROM PASSING THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11732710 ↗
Other CLAMP devices
- ATTUNE 2544-00-001Depuy (Ireland) · CLAMP144 reports
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- Centurion I68080Centurion Medical Products Corporation · CLAMP1 recall0 reports
- ATRAUMATA FB459RAesculap AG · CLAMP1 recall0 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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