GLOBAL UNITE 1100-48-520Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE STANDARD HUMERAL HEAD SIZE 48mm x 21mm · 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 10603295004592), received between Jun 16, 2022 and Jan 20, 2026 — classified as 4 injuries.
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 Problem4
Patient problems
- Unspecified Tissue Injury2
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY ON (B)(6) 2019. OJPT TIME THE ROTATOR CUFF BECOME DEFICIENCY. ON (B)(6) 2026 THE IMPLANT TO A REVERSE TOTAL SHOULDER WITHOUT INCIDENT. DOI- (B)(6) 2019. DOR- (B)(6) 2026. AFFECTED SIDE - LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24119485 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS BEING REVISED DUE TO OVERSTUFFING. HEAD WAS EXCHANGED FOR A SMALLER DIAMETER HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Insufficient Information
MAUDE report 21610138 ↗InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS TORN THEIR ROTATOR CUFF. WE CONVERTED TO A REVERSE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 16994564 ↗InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 14714977 ↗
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-0489-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- Z-0483-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- 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-0486-2022 · Dec 7, 2021 · TerminatedGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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