GLOBAL UNITE 2100-09-001Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE COMMON SET COMPLETE · Class 1
All models of GLOBAL UNITE (91)
Data updated Oct 18, 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 10603295394020), received between Jul 13, 2020 and Jul 14, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2021Break; Break
IT WAS REPORTED THAT THE CASE OF THE HANDLES WAS BROKEN. THE BOTTOM PADS WERE BROKEN AND WHAT'S LEFT WAS SHARP. FOUND WHEN THE SET WAS RETURNED TO THE OFFICE FOR INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12170737 ↗MalfunctionJul 13, 2020Break; Break
IT WAS REPORTED THAT DURING POST CLEANING INSPECTION THE PLASTIC PIECE THAT HOLDS THE SZ6 REAMER IN PLACE IN THE PAN WAS FOUND TO BE BROKEN. ONE OF THE FEET ON THE PAN WAS BROKEN LEAVING A SHARP PIECE OF METAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10267318 ↗
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- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- Calibrate CLCCXSIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501A2Karl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 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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