GLOBAL UNITE 1100-56-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295004776), received between Mar 10, 2021 and Jul 29, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  Patient was revised due to failed rotator cuff, conversion to Delta Xtend. DOI: (b)(6)2018 .DOR: (b)(6)2026.Affected side: Right shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50072428 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. PATIENT HAD HIS LEFT SHOULDER REPLACED SOMETIME AGO, THE EXACT DATE IS UNKNOWN AT THIS TIME. PATIENT DID WELL INITIALLY, OVER THE LAST YEAR, THE PATIENT LOST RANGE OF MOTION, AND EXPERIENCE, PAIN AND DISCOMFORT. SURGEON STATED THE PATIENT HAD A REPAIRABLE ROTATOR CUFF TEAR, AND THAT HE WOULD NEED TO CONVERT THE ANATOMIC CONSTRUCT TO A REVERSE CONSTRUCT. THE ANATOMIC PROXIMAL BODY WAS EXPLANTED ALONG WITH A HUMERAL HEAD, AND ANATOMIC GLENOID. THE HUMERAL SAM WAS LEFT IN SITU. A REVERSE, PROXIMAL BODY, HUMERAL CLUB WARREN PLANTED ONTO THE STEM, A REVERSE BASE PLATE, WITH A GLENOSPHERE WAS IMPLANTED INTO THE GLENOID FOR A REVERSE SHOULDER CONSTRUCT. LOT NUMBERS FOR THE ANATOMIC AND GLENOID AND HUMERAL STEM WERE UNABLE TO BE RECORDED. THERE WAS NO SURGICAL DELAY AS A RESULT OF PRODUCTS. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 18138707 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SINGLE STAGE REVISION OF GLOBAL UNITE ANATOMIC SHOULDER REPLACEMENT DUE TO CONFIRMED INFECTION. HUMERAL HEAD, PROXIMAL BODY AND GLENOID COMPONENT REMOVED, AREA FLUSHED, NEW IMPLANTS PUT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT SHOULDER.

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

  MAUDE report 11945833 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMIARTHROPLASTY APPROXIMATELY 5-7 YEARS AGO OF THE RIGHT SHOULDER. ON (B)(6) 2021, THE HEAD WAS REMOVED. GLENOID COMPONENT WAS PLACED AND A NEW 56X18 HEAD PLACED. THIS IS A CONVERSION TO A TOTAL SHOULDER FOR UNKNOWN REASON. DOI: APPROXIMATELY 5-7 YEARS AGO; DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 11454375 ↗

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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• 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-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-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
• Z-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600