GLOBAL FX 2128-01-020Recalls & reported problems
Depuy Orthopaedics, Inc. · GLOBAL FX INSERTER/EXTRACTOR · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295088028), received between Oct 26, 2017 and Apr 14, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
- Loose or Intermittent Connection1
- Mechanical Jam1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient4
- Not Applicable2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT THE GLOBAL ADVANTAGE BROACH HANDLE AND METAL EXTRACTION TIP BROKE DURING EXTRACTION. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874831 ↗MalfunctionAug 23, 2019Break; Break
IT WAS REPORTED THAT HANDLE WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8926936 ↗MalfunctionJul 29, 2019Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE TIP OF GLOBAL ADVANTAGE BROACH HANDLE BROKE DURING REMOVAL OF A GLOBAL ADVANTAGE STEM. THE BROKEN TIP & HANDLE ARE BEING RETURNED. OTHER METHODS WERE UTILIZED TO REMOVE THE STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8839373 ↗MalfunctionMay 6, 2019Loose or Intermittent Connection; Scratched Material; Loose or Intermittent Connection; Scratched Material
AFTER INVESTIGATION, IT WAS REPORTED THAT THE DEVICE WAS SCRATCHED/NICKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8584197 ↗MalfunctionOct 9, 2018Break; Break
TIP OF INSERTER/REMOVER BROKE OFF OF INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7949430 ↗InjuryDec 18, 2017Break; Break
DURING USE TO EXTRACT THE HUMERAL COMPONENT, THE THREAD OF THE SLAP HAMMER FROM THE EXTRACTION INSTRUMENTS SNAPPED OFF INSIDE THE TOOL. WE WERE NOT ABLE TO REMOVE IT. SIXTY MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT.
Patient problems: Not Applicable
MAUDE report 7125159 ↗InjuryDec 18, 2017Break; Break
DURING USE TO EXTRACT THE HUMERAL COMPONENT, THE THREAD OF THE SLAP HAMMER FROM THE EXTRACTION INSTRUMENTS SNAPPED OFF INSIDE THE TOOL. WE WERE NOT ABLE TO REMOVE IT. A 60 MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT. DOE: (B)(6) 2017.
Patient problems: Not Applicable
MAUDE report 7125158 ↗MalfunctionOct 26, 2017Break; Break
IT WAS REPORTED THAT THE HANDLE CAME OFF WHILE SURGEON REMOVED AN OLD GLOBAL ADVANTAGE STEM AND USED A MALLET ON BROACH HANDLE FOR EXTRACTION.
Patient problems: No Information
MAUDE report 6980046 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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