GLOBAL UNITE 1100-20-310Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE COLLAR ECCENTRIC SIZE 48 · Class 2 · Implant
All models of GLOBAL UNITE (91)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295004271), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 injury.
8 other recalls cover devices cleared under the same FDA submission (K101996, K170748); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SURGEON REVISED THE FAILED FRACTURE HEMI TO REVERSE TOTAL SHOULDER. THERE WAS NO IMPLANT FAILURE, CUFF FAILURE. DOI UNKNOWN, DOR (B)(6) 2025, AFFECTED SIDE- RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 23305318 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K101996, K170748. One submission often covers many models, so check the product and lot details in each record.
- Z-0488-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- Z-0487-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- Z-0483-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Z-0489-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- Z-0484-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
- Z-0490-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- Z-0486-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- Z-0485-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- BIO-MODULAR SHOULDER SYSTEM 113865Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114648Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113863Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113867Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 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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