GLOBAL UNITE 1100-40-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295004479), received between Aug 2, 2017 and Apr 1, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Disassembly” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT SHOULDER GLOBAL UNITE ANATOMIC IMPLANT WAS IN SITU BUT HAS FAILED AND ROTATOR CUFF NON FUNCTIONING. A REVERSE SHOULDER REPLACEMENT WAS THEREFORE REQUIRED SO THE ANATOMIC IMPLANTS WERE REPLACED WITH REVERSE SHOULDER IMPLANTS. THE HEAD, COLLAR AND FRACTURE EPIPHYSIS WERE REMOVED DURING THE REVISION SURGERY AND REPLACED WITH A DELTA XTEND EPIPHYSIS AND PE CUP. THERE WAS NO DELAY TO PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21747758 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMI ARTHROPLASTY WITH GLOBAL UNITE IMPLANTS AS A RESULT OF A FRACTURE IN 2022. DUE TO PAIN AND POOR FUNCTION, SURGEON CONVERTED TO A DELTA EXTEND REVERSE TSA TODAY. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20013501 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 14112406 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORE ROTATOR CUFF (SUB SCAP) NEEDED TO CONVERT TO REVERSE FOR STABILITY AND ROM. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER AFFECTED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Unspecified Musculoskeletal problem

  MAUDE report 13584664 ↗
• InjuryAug 2, 2017Disassembly; Material Separation; Disassembly; Material Separation

  REVISION FOLLOWING A FRACTURE OF A GLOBAL UNITE HEAD. UPDATE JULY 4, 2017: ADDITIONAL INFORMATION RECEIVED INDICATING THE PATIENT WAS REVISED DUE TO DISASSEMBLY OF THE HEAD. DOI UPDATED AND ADDED PATIENT DEMOGRAPHICS. PART AND LOT NUMBERS ARE ADDED INTO THE COMPLAINT RECORD. THIS COMPLAINT WAS UPDATED ON JULY 4, 2017. UPDATE JULY 31, 2017: ADDITIONAL INFORMATION RECEIVED INDICATING THE PATIENT UNDERWENT SURGICAL REVISION WITH JOINT SYNOVECTOMY AND CHANGE OF HEAD AND HUMERAL METAPHYSIS. IT WAS REPORTED THAT THERE IS SYNOVITIS WITH METALLOSIS AT THE GLENOID. THIS COMPLAINT WAS UPDATED ON JULY 31, 2017.

  Patient problems: Foreign Body Reaction; No Information; Synovitis

  MAUDE report 6760527 ↗

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-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• 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-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
• Z-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• 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