GLOBAL UNITE 1100-60-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295004790), received between Nov 29, 2017 and Apr 3, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K133834, 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.

• 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 19034330 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HER SHOULDER REPLACED SOMETIME AGO BY A SURGEON WHO IS UNKNOWN. THE PATIENT DID WELL INITIALLY AND THEN EXPERIENCED CUFF TEAR ARTHROPLASTY AND BEGAN TO LOOSE FUNCTION. THE SURGEON REVISED THIS ANATOMIC UNITE CONSTRUCT TO A DELTA REVERSE CONSTRUCT. THE HUMERAL HEAD, THE HUMERAL BODY, AND THE GLENOID COMPONENT WERE EXPLANTED AND REPLACED WITH REVERSE COMPONENTS. THE HUMERAL STEM WAS LEFT IN-SITU. THE ANCHOR GLENOID WAS NOT RECORDED ON THIS SHEET BECAUSE THE CATALOGUE AND LOT WERE ILLEGIBLE. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17939678 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PLACED. THE STEPTECH GLENOID IMPLANT CURRENTLY REMAINS IN. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8735084 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7068921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133834, K170748. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-1012-2018 · Nov 28, 2017 · Terminated
  The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pd