GLOBAL UNITE 1100-44-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295004516), received between May 25, 2018 and Jun 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONVERTED PATIENT FROM A TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY. THEY REMOVED THE SIZE 10 PROXIMAL BODY, SIZE 44X15 STANDARD HUMORAL HEAD AND A SIZE 44 ANCHOR PEG GLENOID. THE PATIENT HAD A ROTATOR CUFF TEAR WHICH LED TO A CONVERSION OF A TSA TO AN RSA. AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25664855 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A CUFF TEAR, DURING WHICH ALL COMPONENTS EXCEPT THE STEM WERE REMOVED AND THE CASE WAS CONVERTED FROM AN ANATOMIC SHOULDER TO A REVERSE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23688449 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 20127869 ↗
• 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 16796873 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON TOLD SALES REP IN THE AM ON (B)(6) 2022 HE WAS REVISING A PATIENT HEMI ARTHROPLASTY THAT AFTERNOON AND ASKED HIM TO LOOK AT X-RAYS. HE TOLD HIM IT APPEARED TO BE A UNITE STEM CONSTRUCT AND THAT HE WOULD BE ABLE TO CONVERT TO A REVERSE CONSTRUCT IF HE WOULD LIKE. SURGEON WAS REVISING THIS CONSTRUCT BECAUSE OF CUFF DEFICIENCY WHICH WAS CAUSING LACK OF ROM AND PAIN. HE EXPLANTED THE UNITE PROXIMAL BODY, THE HUMERAL HEAD AND CONVERTED THE CONSTRUCT TO A REVERSE SHOULDER. THE UNITE STEM WAS LEFT IN SITU. THE ORIGINAL DATE OF SURGERY AND WHO DID THE SURGERY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

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

  MAUDE report 15494934 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT THE PRIMARY PROCEDURE (ARTIFICIAL BONE HEAD INSERTION) FOR TREATING PROXIMAL HUMERAL FRACTURE. IT BECAME OBVIOUS THAT THE RANGE OF MOTION HAD BECOME MORE RESTRICTED AS TIME PASSED. ON (B)(6) 2021, AN RSA WAS PERFORMED TO REPLACE THE DEVICES IN QUESTION WITH DELTA EXTEND SYSTEM TO SECURE THE RANGE OF MOTION. THE STEM (UNK) WAS REUSED.

  Patient problems: Loss of Range of Motion

  MAUDE report 13042772 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8240533 ↗
• InjuryAug 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOSS OF FUNCTION. DOI: (B)(6) 2015; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Disorder; Loss of Range of Motion; Not Applicable; Pain

  MAUDE report 7832171 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THE PATIENT HAS A HEMI SHOULDER BUT HAD PAIN AND LIMITED MOTION. SURGEON WANTED TO CONVERT TO REVERSE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Not Applicable; Pain

  MAUDE report 7544473 ↗

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-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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• Z-0489-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
• 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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100