GLOBAL UNITE 1100-20-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295004301), received between Feb 28, 2019 and Feb 28, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FRACTURED AT RIGHT SHOULDER BACK IN 2013 AND HAD A HEMI ARTHROPLASTY REPLACEMENT USING A GLOBAL UNITE FX IMPLANT. SURGEON'S OFFICE CALLED AND SCHEDULED A SURGERY REQUESTING DEPUY EQUIPMENT TO CONVERT THE GLOBAL UNITE FX HEMI CONSTRUCT TO A REVERSE SHOULDER CONSTRUCT. SURGEON EXPLANTED THE HUMERAL HEAD IMPLANT, THE SUTURE COLLAR, AND THE PROXIMAL BODY AND LEFT THE WELL FIXED STEM IN PLACE. THE CONVERSION INSTRUMENTATION WAS USED AND A NEW REVERSE SHOULDER CONSTRUCT WAS IMPLANTED. DOI: (B)(6) 2013; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8377808 ↗

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-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-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-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100