GLOBAL UNITE 1100-48-500Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE STANDARD HUMERAL HEAD SIZE 48mm x 15mm · Class 2 · Implant
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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295004578), received between Apr 23, 2018 and Oct 18, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Fitting Problem” (1 report).
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 Problem2
- Fitting Problem1
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Loss of Range of Motion1
- No Code Available1
- Not Applicable1
- Pain1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED WITH ANATOMIC UNITE SHOULDER CONVERSION TO DELTA XTEND DUE TO SUBSCAPULARIS INJURY. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 17958188 ↗InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INFECTION AND ROTATOR CUFF DEFICIENCY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020. DOR:(B)(6) 2021. LEFT SHOULDER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11960010 ↗InjuryDec 20, 2018Fitting Problem; Fitting Problem
PATIENT REVISED DUE TO FRACTURE.
Patient problems: Bone Fracture(s); No Code Available
MAUDE report 8185502 ↗InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS PAIN AND LIMITED MOBILITY. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT SHOULDER.
Patient problems: Loss of Range of Motion; Not Applicable; Pain
MAUDE report 7450711 ↗
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-0483-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Z-0488-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- Z-0484-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
- Z-0485-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
- Z-0490-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- Z-0487-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- Z-0486-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- Z-0489-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
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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