GLOBAL UNITE 1100-40-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295004493), received between Jul 26, 2018 and Feb 8, 2023 — 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.

• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 16329561 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A STIFF SHOULDER. THE SURGEON EXPLANTED THE 40X15 ECC UNITE HEAD AND PUT IN 40X12 UNITE STD HEAD FOR BETTER RANGE OF MOTION. NO FURTHER INFORMATION ABOUT THIS PATIENT OR CASE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Muscular Rigidity

  MAUDE report 13636132 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD WAS REMOVED AND REPLACED. SCARING MENTIONED AS A POSSIBLE CAUSE OF PAINFUL SHOULDER. ALL IMPLANTS WERE CONSIDERED WELL POSITIONED AND WELL FIXED. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: No Code Available; Pain; Scarring

  MAUDE report 9181379 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND RANGE OF MOTION ISSUES. SURGEON REMOVED OSTEOPHYTES AND CHANGED HEAD FROM ECCENTRIC TO STANDARD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7723055 ↗

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-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0485-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100