GLOBAL UNITE 1100-40-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295004424), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY PLAN TO CONVERT A GLOBAL UNITE PROXIMAL BODY TO AN EPIPHYSIS FOR A REVERSE SHOULDER ARTHROPLASTY. SURGEON WAS UNABLE TO "UNSCREW" THE PROXIMAL BODY FROM THE STEM. THE STEM/BODY CONSTRUCT WAS IMPLANTED IN THE PATIENT. THE SURGEON ENDED UP REMOVING THE ENTIRE STEM/BODY CONSTRUCT. TWO HEX SCREWDRIVERS WERE BROKEN TRYING TO REMOVE SCREW. A SURGICAL DELAY OF 30 MINUTES WAS ALSO REPORTED. DOI: UNKNOWN; DOR: (B)(6) 2021; RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 12065517 ↗

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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• 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-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-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• 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