GLOBAL ICON 1140-20-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295381259), received between Jan 29, 2020 and Mar 7, 2024 — classified as 2 injuries.

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.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2023, (RIGHT SHOULDER). TREATMENT: REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 18857862 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BURSITIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT SHOULDER).

  Patient problems: No Code Available

  MAUDE report 9641659 ↗