GLOBAL UNITE 1100-20-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295433217), received between Jan 8, 2018 and May 29, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SUBSCAP FAILURE CONVERTED FROM A TOTAL SHOULDER TO REVERSE, KEEPING THE DISTAL STEM IN PLACE. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25334635 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GLOBAL UNITE HEMI WAS REVISED TO REVERSE TSR DUE TO ROTATOR CUFF FAILURE. DOI: UNKNOWN DATE IN 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24405478 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO CUFF TEAR. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23407374 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REVISED TO CONVERT TO A REVERSE BECAUSE OF CUFF TEAR. ORIGINAL DATE OF SURGERY IS UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23082590 ↗
• InjuryMay 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO MECHANICAL FAILURE/DISLOCATION AFTER HAVING MULTIPLE SCLEROSIS. SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21955296 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISES DUE TO THE FAILURE OF THE ROTATOR CUFF. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21857165 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. THE PATIENT DISRUPTED / TORE ROTATOR CUFF BUT DID NOT PRESENT TO SURGEON UNTIL ONE YEAR LATER. THE HUMERUS WAS COMPLETELY SCARRED IN AND IN A FIXED ANTERIOR POSITION. DOCTOR FELT REVISION TO REVERSE WOULD BE UNSTABLE. CHOSE TO CONVERT TO A 145 EPI AND A 48X26MM CTA HEAD. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 20610478 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIOR TOTAL SHOULDER SURGERY YEARS AGO AND RECENTLY TORE THEIR ROTATOR CUFF. SURGEON CONVERTED A WELL FIXED GLOBAL UNITE IMPLANT TO A DELTA XTEND. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN; OVER 20 YEARS AGO. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20426940 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PRIMARY SURGERY PERFORMED ON (B)(6) 2019. AFTER SURGERY, IT WAS CONFIRMED THAT GREATER TUBERCLE WAS ATROPHIED. THEREFORE, THE IMPLANTS WILL BE REMOVED, AND RSA WILL BE PERFORMED BY OTHER COMPANY¿S PRODUCT. THE REVISION SURGERY DATE IS (B)(6) 2023. DURING THE PRIMARY SURGERY IMPLANT INSERTION, A CRACK WAS CONFIRMED IN THE GREATER TUBERCLE. THE SURGEON COMMENTED THAT THE CRACK WAS A POSSIBLE CAUSE OTHER THAN THE PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16796901 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 16322174 ↗
• MalfunctionNov 22, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED SHE HAD MULTIPLE DOCTORS REVIEW X-RAYS AND THAT THEY SAID THE ITEM WAS TOO LARGE AND SITTING PROUD OR TOO HIGH. SHE HAS SINCE HAD ISSUES WITH THE SURGERY AND EXPERIENCED PAIN. DOI: (B)(6) 2022. RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 15843005 ↗
• 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 13584670 ↗
• MalfunctionOct 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SET SCREW IN THE ANATOMIC BODY FELL OUT OF BODY AFTER PACKAGE OPENED. THE SURGEON WAS NOT COMFORTABLE USING IT BECAUSE COULDN¿T BE SURE IT WASN¿T DEFECTIVE IN SOME WAY. NO SURGICAL DELAY. (RIGHT KNEE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684862 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT UNDERWENT PRIMARY TOTAL SHOULDER REPLACEMENT IN (B)(6) 2016. HISTORY OF INFECTED PROSTHETIC JOINT. SURGEON WHO PERFORMED PRIMARY SURGERY ATTEMPTED REMOVAL OF PROSTHESIS (DATE UNKNOWN). ONLY PROSTHETIC HEAD WAS REMOVED AS STEM WAS TOO WELL FIXED, AND UNABLE TO BE REMOVED. REVISION SURGEON REMOVED HUMERAL STEM, MULTIPLE SPECIMENS COLLECTED. COMPETITOR PROSTHESIS IMPLANTED, USING CUSTOM GLENOID PROSTHESIS AS WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10919495 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROX. 2 YEARS POST TSA. ELDERLY PATIENT WITH SIGNIFICANT CO-MORBIDITIES (ACCORDING TO SURGEON), WITH OSTEOPOROTIC BONE. PATIENT PRESENTED WITH PAIN AND DECREASED RANGE OF MOTION 6 MONTHS AGO. CT SCAN SHOWED LOOSENING OF GLENOID COMPONENT - SURGEON HAD USED BONE GRAFT AROUND CENTRAL PEG OF GLENOID COMPONENT, CEMENTED PERIPHERAL PEGS. GLOBAL UNITE HEAD AND PROXIMAL BODY REMOVED TO ACCESS GLENOID COMPONENT. GLENOID COMPONENT EASILY REMOVED. HEAD, PROXIMAL BODY AND APG+ GLENOID COMPONENT ALL SENT OFF FOR MICROSCOPY / CULTURE. MULTIPLE SOFT TISSUE SPECIMENS ALSO TAKEN. DISTAL UNITE STEM (REF. 110008100) AND BIOSTOP KEPT INSITU. REPLACEMENT APG+ GLENOID (44MM) IMPLANTED, CEMENT USED IN ALL PEGS. NEW UNITE PROXIMAL BODY AND HEAD - SAME SIZES AS REMOVED, ALSO IMPLANTED. SHOULDER STABLE ON REDUCTION.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 10301734 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. ROTATOR CUFF FAILURE AND CONVERSION TO A RTSA DONE. DOI: (B)(6) 2015, DOR: (B)(6) 2019, UNKNOWN SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 9425959 ↗
• MalfunctionOct 5, 2018Packaging Problem; Packaging Problem

  IT IS REPORTED THAT THE PLASTIC WRAP ON THE OUTSIDE OF MANY OF THE GLOBAL UNITE ANATOMIC BODIES WAS VERY INCONSISTENT AND LOOKED VERY SLOPPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7939211 ↗
• InjuryJan 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE PREVIOUS HUMERAL COMPONENTS WERE SEATED TOO HIGH DUE TO DIFFICULT PATIENT ANATOMY. THEY WERE REMOVED AND NEW COMPONENTS WERE CORRECTLY PLACED. DOI: (B)(6) 2017. DOR: (B)(6) 2017. LEFT SHOULDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171353 ↗

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-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• 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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• 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-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-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