GLOBAL UNITE 1100-48-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295004608), received between Mar 30, 2023 and Sep 28, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918202 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS LEFT SHOULDER PAIN. SUBSCAP DYSFUNCTION.

  Patient problems: Pain

  MAUDE report 24402962 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INCOMPETENT ROTATOR CUFF SO IMPLANT WAS REVISED FROM A PRIMARY TOTAL SHOULDER TO A REVERSE TOTAL SHOULDER. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23346470 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANATOMIC TO REVERSE SURGERY. THERE WAS ROTATOR CUFF FAILURE. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22937774 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUBSCAP FAILURE. IT WAS CONVERTED TO REVERSE KEPT DISTAL STEM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20800449 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, REVISION WAS COMPLETED, DUE TO ROTATOR CUFF ARTHROPATHY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19689525 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17939718 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ANATOMIC SHOULDER REPLACEMENT AT (B)(6) HOSPITAL IN (B)(6) 2022, UNSURE OF THE DATES. SHE PRESENTED WITH ROTATOR CUFF FAILURE AND REQUIRED CONVERSION FROM GLOBAL UNITE ANATOMIC TO DELTA XTEND REVERSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16642951 ↗

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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• 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-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
• 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