GLOBAL UNITE 1100-52-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295004707), received between Nov 7, 2019 and Feb 7, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE 1ST STAGE REVISION DUE TO INFECTION AND 3 IMPLANTS WERE REMOVED. ORIGINAL OPERATION DUE TO HUMERAL FRACTURE. IMPLANTS USED GLOBAL UNITE FRACTURE HEMI ARTHROPLASTY RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21337294 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A GLOBAL UNITE HEMIARTHROPLASTY PREVIOUSLY DONE BY A DIFFERENT SURGEON ON AN UNKNOWN DATE. OVER TIME, THE GLENOID BONE HAD WORN DOWN AND THE PATIENT WAS EXPERIENCING PAIN. THE DOCTOR REVISED THIS PATIENT BY RESURFACING THE GLENOID WITH A 48MM +3 STEPTECH GLENOID IMPLANT AND A 52X21MM GLOBAL UNITE HUMERAL HEAD. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 21136649 ↗
• InjuryDec 22, 2022Fracture; Fracture

  PATIENT HAD SHOULDER HEMIARTHROPLASTY PERFORMED IN 2014, IT HAS RECENTLY BECOME UNSTABLE AND REQUIRED REVISION TO TOTAL. SUPERIOR-POSTERIOR WHICH REQUIRED CORRECTION WHEN REAMING, ALSO THE PROXIMAL BODY WAS REVISED FROM 135DEG TO 142DEG TO HELP IMPROVE STABILITY FURTHER. DOI: 2014. DOR: (B)(6) 2022. UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 16033376 ↗
• InjuryDec 14, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT TOLD SURGEON THAT HE WASN'T HAVING A LOT OF PAIN BUT WASN'T GETTING THE ROM THAT HE HAD BEEN GETTING. THIS PATIENT HAD A LEFT HEMI SHOULDER REPLACEMENT DONE FOR A FRACTURE BACK ON (B)(6) 2015. THE SURGEON THOUGHT THAT MAYBE HE HAD OVER-STUFFED THE JOINT AND WANTED TO REMOVE THE HEAD/COLLAR AND PUT ON A SMALLER HEAD. THE SURGEON REMOVED THE HEAD/COLLAR AND TRIALED WITH A 44 HEAD. HE SAID THAT HE FELT THAT IT IMPROVED THE STABILITY. HE THEN CLOSED THE PATIENT UP AND WAS HAPPY WITH THE RESULT. THE SURGEON FELT HE NEEDED TO DOWNSIZE THE HEAD SO STABILITY AND LACK OF ROM WAS THE MAIN ISSUE FROM WHAT I UNDERSTOOD TALKING WITH THE SURGEON. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2015, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11003596 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PARTIAL CUFF TEAR. GLOBAL UNITE PRIMARY CONVERTED TO REVERSE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9289937 ↗

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-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• 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-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-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• 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