GLOBAL UNITE 1407-20-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295444749), received between Jul 24, 2019 and Nov 5, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT BOTH PRODUCTS COULD NOT BE PROPERLY CONNECTED TO EACH OTHER. THERE WAS A REMAINING GAP OF 2CM. NO APPRECIABLE OP TIME DELAY. NO PATIENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478940 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SUSPICION OF PROSTHETIC INFECTION - LEFT SHOULDER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: (B)(6) 2024 (LEFT SHOULDER) TREATMENT: I&D NO REVISION COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19563226 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED REVERSE TOTAL SHOULDER. ALL IMPLANTS WERE REMOVED AND A SPACER WAS IMPLANTED. THERE WAS NO LOOSENING. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19446613 ↗
• InjuryApr 2, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SHOULDER DELTA MOTION POST HUMERAL FRACTURE DUE TO INFECTION INFECTION AND LOOSENING AT THE STEM HUMERAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 19018684 ↗
• InjuryAug 29, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM. THE SURGEON REMOVED AND REPLACED HUMERAL STEM AND RETAINED ORIGINAL GLENOID COMPONENTS. DOI: (B)(6) 2020 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17642526 ↗
• MalfunctionJan 13, 2023Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY, DURING INITIAL SHOULDER-TEP IMPLANTATION, IT WAS NOT POSSIBLE TO FIX THE INLAY INTO THE EPIPHYSIS. ANOTHER EPIPHYSIS WAS AVAILABLE AND THE INLAY-EPIPHYSIS-CONSTRUCT WAS IMPLANTED WITHOUT ISSUES. SURGICAL DELAY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159516 ↗
• MalfunctionNov 16, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT LOCKING BOLT IN THE EPI WAS STRIPPED AND SURGEON COULDN¿T FULLY TIGHTEN IT TO THE STEM & REQUESTED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824161 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE HUSBAND OF THE PATIENT THOUGHT THE INFECTION WAS CAUSED BY THE IMPLANT. DOI: (B)(6) 2019; DOI: (B)(6) 2019 (PE CUP); DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8910562 ↗
• MalfunctionJul 24, 2019Loss of Osseointegration; Loss of Osseointegration

  SURGEON FROM (B)(6) HOSPITAL HAS REPORTED THAT ANOTHER PATIENT HAS PRESENTED TO HIM WITH A ROTATIONALLY UNSTABLE STEM. PLEASE SEE DETAILS BELOW; ISSUE: ROTATIONALLY UNSTABLE STEM. PRODUCT: GLOBAL REVERSE FRACTURE EPIPHYSIS (1407-20-101), GLOBAL UNITE STEM (TBA), STANDARD DELTA XTEND CUP (TBA) & GLENOID COMPONENTS (TBA) ¿ UNCEMENTED TECHNIQUE USED ¿ NO CEMENT USED DISTALLY. PATIENT: MID TO LATE 50¿S, COMPLIANT, NON-SMOKER. INTRA OPERATIVE: SUCCESSFUL OP, PATIENT PRESENTED AS NON-UNION. WAS FIXED WITH DELTA XTEND USING GLOBAL REVERSE FRACTURE EPI (CENTERED COMPONENT). POST OPERATIVE: COMPLIANT PATIENT, LIGHT REHAB. AFTER 5 MONTHS, REHAB INCREASED. IT THEN SEEMS THE STEM BECAME LOOSE. ACTION: PATIENT AWAITING DATE FOR REVISION SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8822166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170748. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0483-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
• 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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• 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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100