GLOBAL UNITE 2100-01-135Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE ANATOMIC IMPLANT HOLDER · Class 1
All models of GLOBAL UNITE (91)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295430322), received between Oct 25, 2019 and Dec 18, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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
- Device-Device Incompatibility4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STEM INSERTION HANDLE SNAPS OPEN WHEN STUCK WITH A MALLET. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347451 ↗MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility
THE ALIGNMENT ROD WOULD NOT FIT INTO THE VERSION HOLE AT THE TOP OF THE HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13100556 ↗MalfunctionOct 30, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTOR HANDLE WOULD RELEASE WHEN HIT WITH A MALLET TO INSERT THE TRIAL STEM AND IMPLANT STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10762922 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
DOESN'T LOCK ON PROXIMAL BODY CORRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241523 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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.
How reports and recalls are matched · Editorial policy · Report an error on this page