GLOBAL UNITE 1100-20-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295433224), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K133834, 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2017Material Separation; Material Separation

  SECOND REVISION OF A BROKEN GLOBAL UNITE HEAD PLANNED FOR (B)(6) 2017. FIRST REVISION OCCURRED ON (B)(6) 2017 FOR THE EXACT SAME ISSUE. THE SURGEON WILL IMPLANT A REVERSE PROSTHESIS. UPDATE 7-31-2017: TRANSLATED MEDICAL RECORDS (B)(6) 2017 HAVE BEEN REVIEWED. OPERATIVE NOTE INDICATES THE PATIENT RECEIVED A REVISION LEFT TOTAL SHOULDER THROUGH REVERSAL OF ENTIRE PROSTHESIS AND SYNOVECTOMY DUE TO DISASSEMBLY OF PROSTHETIC HEAD THROUGH HUMERAL PROSTHESIS OF THE LEFT SHOULDER. THE SURGEON NOTES SYNOVIAL HYPERTROPHY WITH NUMEROUS METAL INCLUSIONS AT THE LOWER PART OF THE SUBSCAPULARIS. HE ALSO NOTES THAT THE PROSTHESIS HEAD HAS DISASSEMBLED FROM THE METAPHYSEAL MORSE TAPER AND IS LOOSE IN THE JOINT. HE NOTES SYNOVIAL HYPERTROPHY WITH METALLOSIS, PREVAILING ON THE GLENOID SIDE. PLEASE NOTE, THE HUMERAL HEAD WAS INITIALLY REPORTED AS BROKEN/FRACTURED, HOWEVER, THE MEDICAL RECORDS INDICATE IT BECAME DISASSEMBLED FROM THE HUMERAL PROSTHESIS, NOT FRACTURED. UPDATED ON 8-15-2017.

  Patient problems: Foreign Body Reaction; Synovitis; Tissue Damage

  MAUDE report 6829957 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133834, K170748. One submission often covers many models, so check the product and lot details in each record.

• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-1012-2018 · Nov 28, 2017 · Terminated
  The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pd