GLOBAL UNITE 1100-12-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295004134), received between Dec 2, 2020 and Jun 25, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT JUNCTION BETWEEN THE STEM WAS NOT CONNECTING TO THE PROXIMAL BODY. DOE: JUNE 10, 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19603884 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S SHOULDER WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND AN ABX SPACER WAS IMPLANTED. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, UNKNOWN SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10935700 ↗

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-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
• 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-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600