GLOBAL UNITE 1100-30-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295004394), received between Jul 26, 2017 and Oct 15, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED THE FAILED FRACTURE HEMI TO REVERSE TOTAL SHOULDER. THERE WAS NO IMPLANT FAILURE, CUFF FAILURE. DOI-UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23305313 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT SHOULDER GLOBAL UNITE ANATOMIC IMPLANT WAS IN SITU BUT HAS FAILED AND ROTATOR CUFF NON FUNCTIONING. A REVERSE SHOULDER REPLACEMENT WAS THEREFORE REQUIRED SO THE ANATOMIC IMPLANTS WERE REPLACED WITH REVERSE SHOULDER IMPLANTS. THE HEAD, COLLAR AND FRACTURE EPIPHYSIS WERE REMOVED DURING THE REVISION SURGERY AND REPLACED WITH A DELTA XTEND EPIPHYSIS AND PE CUP. THERE WAS NO DELAY TO PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21747773 ↗
• InjuryJul 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATED THAT THE SURGEON TRIED TO CONVERT FROM UNITE FX TO REVERSE. THE PROXIMAL BODY SCREW WAS LOOSENED UP AND BODY WOULD NOT RELEASE FROM THE UNITE STEM. THEN THE STEM CAME OUT WHEN TRYING TO REMOVE THE BODY. THEY HAD TO PUT IN DELTA SYSTEM.

  Patient problems: No Information

  MAUDE report 6743871 ↗

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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600