GLOBAL UNITE 1100-52-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295004721), received between Apr 23, 2018 and Dec 3, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S SHOULDER CONVERTED FROM AN ATOMIC TO REVERSE DUE TO FAILURE OF THE ROTATOR CUFF. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23704873 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ROTATOR CUFF FAILURE LEADING TO CONVERSION OF ANATOMICAL SHOULDER TO REVERSE SHOULDER REPLACEMENT IN RIGHT ARM DOMINANT BUILDER. SURGEON SAYS THE PATIENT JUST WORE IT OUT FROM OVERUSE; HE ADVISED IT WAS NOT AN IMPLANT FAILURE. PATIENT EXPERIENCED PAIN AND INSTABILITY AS A RESULT OF THE EVENT.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 23368997 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TOTAL SHOULDER EXPLANTED FOR INFECTION. THE GLENOID WAS LOOSE AND WORN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19034334 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TOTAL SHOULDER REPLACEMENT - CONVERTED TO REVERSE SHOULDER DUE TO ROTATOR CUFF FAILURE CAUSING PAIN AND REDUCED FUNCTION. RIGHT SHOULDER . ALL COMPONENTS EXPLANTED AND REPLACED WITH REVERSE SHOULDER. DOI: (B)(6) 2022. DOE: (B)(6) 2024.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 18857366 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT. - WE REVISED THE SHOULDER AS DESCRIBED IN THE PC. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? - SURGICAL DELAY QUESTION IS NOT REALLY APPLICABLE AS THE ENTIRE SURGERY WAS A REVISION.

  Patient problems: Pain

  MAUDE report 18836368 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. EXPLANTED THE PROXIMAL BODY OF THE GLOBAL UNITE STEM, THE GLOBAL HEAD AND ANCHOR PEG GLENOID. DOI: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 17649979 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S TOTAL SHOULDER WAS REVISED DUE TO CUFF TEAR. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16876579 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD TO GO BACK IN TO REPAIR THE PATIENT¿S SUBSCAPULARIOUS. THERE WERE NO PROBLEMS WITH THE IMPLANTS. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 14084654 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A CUFF TEAR. TOTAL SHOULDER REVISED TO A REVERSE. WHILE IN REVISION, IT WAS NOTICED THAT PART NUMBER 230785000 WAS IN THE JOINT FROM THE PRIOR SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9878735 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ANATOMIC TOTAL SHOULDER REPLACEMENT, WITH SUBSEQUENT ROTATOR CUFF FAILURE, REQUIRING CONVERSION TO REVERSE SHOULDER REPLACEMENT.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9714060 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS SHOULDER PAIN. SURGEON REMOVED THE HUMERAL HEAD AS WELL AS THE GLENOID AND ONLY REPLACED THE HUMERAL HEAD. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Not Applicable; Pain

  MAUDE report 7451653 ↗

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