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GLOBAL UNITE 1100-44-620Recalls & reported problems

Depuy (Ireland) · GLOBAL UNITE ECCENTRIC HUMERAL HEAD SIZE 44mm x 21mm · Class 2 · Implant

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 10603295004561), received between Jul 13, 2018 and Jul 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryJul 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT THE LOOSENING INTERFACE IS BETWEEN ANCHOR PEG GLENOID IMPLANT AND THE GLENOID BONE IS WHERE THE SURGEON DETERMINED IT WAS LOOSE. THE AFFECTED SIDE WAS ON THE LEFT SIDE.

    Patient problems: Pain

    MAUDE report 7685009 ↗

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

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.