GLOBAL UNITE 1100-52-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295004714), received between Apr 20, 2018 and Mar 31, 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CONCERN FOR GLENOID COMPONENT LOOSENING/POLY WEAR RESULTING IN PAIN AND DYSFUNCTION IN RIGHT SHOULDER. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: PROBABLE, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 1 JAN 2026, DATE OF IMPLANT: (B)(6) 2013, DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT SHOULDER. TREATMENT/IMPACT: ASPIRATION: YES. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 113643026 LOT NUMBER: 348444 COMPONENT TYPE: ANCHOR DESCRIPTION: PREMIERON XLINKED GLENOID ANCHOR PEG 52MM. CATALOG NUMBER: 113014000 LOT NUMBER: 351106 COMPONENT TYPE: STEM DESCRIPTION: GLOBAL HUMERAL STEM SZ 14. CATALOG NUMBER: 110052520 LOT NUMBER: FK1JD1 COMPONENT TYPE: HEAD DESCRIPTION: GLOBAL UNITE HEAD 52X21 STD. CATALOG NUMBER: 113002000 LOT NUMBER: 371961 COMPONENT TYPE: TAPER ASSEMBLY DESCRIPTION: GLOBAL AP TAPER ASSEMBLY 135 DEGREE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24743581 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE SUBSCAP AND SURGEON DECIDED TO REPAIR SUBSCAP AND DOWNSIZE HEAD FROM A 21 TO AN 18. DOI: UNKNOWN. DOR: (B)(6) 2024 AFFECTED AFFECTED: UNKNOWN SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20914069 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND LACK OF ROM. PATIENT HAD PREVIOUS PROXIMAL HUMERUS FX AND THE SURGEON USED UNITE FX STEM, SUTURE COLLAR, AND HUMERAL HEAD IMPLANTS. SURGEON THEN REVISED THE HEMI SHOULDER TO A REVERSE TOTAL SHOULDER WITH A DIFFERENT COMPANY (TORNIER). THERE WERE NO DEFICIENCIES SUGGESTED AND NO DELAY IN PROCEDURE. IMPLANTS WERE NOT AVAILABLE FOR RETURN. DOI: (B)(6)2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14944569 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PAINFUL AND STIFF RIGHT TOTAL SHOULDER ORIGINAL DATE OF SURGERY (B)(6) 2014. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:PATIENT NEEDED REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:PATIENT WAS REVISED TO A SMALLER HUMERAL HEAD IMPLANT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Pain

  MAUDE report 7446249 ↗

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-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-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100