GLOBAL UNITE 1100-30-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295004387), received between Dec 7, 2017 and Mar 26, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ROTATOR CUFF DYSFUNCTION FOLLOWING LEFT SHOULDER HEMIARTHROPLASTY FOR FRACTURE. UNKNOWN SURGICAL DELAY. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18977776 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A HUMERAL HEAD REPLACEMENT TREATING FRACTURE OF PROXIMAL END OF HUMERUS PERFORMED ON (B)(6) 2022. THE SURGEON INSERTED A BONE PLUG AT FIRST AND INJECTED CEMENT INTO THE MEDULLARY CAVITY. AFTER THAT, THE SURGEON NOTICED A SMALL CRACK (A LITTLE LESS THAN 1 CM) AT THE SHAFT OF HUMERUS. CHECKING THE AFFECTED AREA BY AN IMAGE INTENSIFIER, THE SURGEON JUDGED THAT THE CRACK WAS NOT SUCH A SERIOUS PROBLEM, AND GLOBAL UNITE BODY WAS INSERTED. THE AFFECTED AREA WAS FIXED FIRMLY/PROPERLY WITH CEMENT. THE CONDITION OF THE AFFECTED AREA WAS ALSO CONFIRMED BY X-RAY AT THE END, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. THE SURGEON SAID THE CRACK WAS CAUSED BECAUSE THE SURGEON INSERTED THE GLOBAL UNITE BODY IN A SLIGHT MISDIRECTION. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Unspecified Tissue Injury

  MAUDE report 15624659 ↗
• 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 13042754 ↗
• 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 7832163 ↗
• MalfunctionDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON COULD NOT CONNECT HUMERAL STEM AND BODY COMPONENT DURING THE SURGERY BECAUSE THE SHAFT OF THE SCREW PART TO BE CONNECTED WITH THE STEM OF THE BODY OF THE EQUIPMENT WAS INSTALLED UPSIDE DOWN WHEN THE SURGEON OPENED THE PACKAGE. AFTER THE SURGERY, THE SURGEON FOUND THAT IT WAS POSSIBLE TO REASSEMBLE THE SCREW SHAFT IN THE CORRECT ORIENTATION BY HAND. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS 5 MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7099959 ↗
• MalfunctionDec 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCOUNT NAME: (B)(6). THE REPORTED DEVICE WAS GOING TO USE FOR ARTIFICIAL SHOULDER HEAD INSERTION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE SURGEON COULD NOT CONNECT HUMERAL STEM (10MM STANDARD) AND BODY COMPONENT (THE REPORTED DEVICE) DURING THE SURGERY BECAUSE THE SHAFT OF THE SCREW PART TO BE CONNECTED WITH THE STEM OF THE BODY OF THE EQUIPMENT WAS INSTALLED UPSIDE DOWN WHEN THE SURGEON OPENED THE PACKAGE. (PLEASE SEE PHOTO 1). THE SURGERY WAS COMPLETED BY USING THE DEVICE WHICH THE SURGEON REASSEMBLED THE SCREW SHAFT IN CORRECT ORIENTATION BY USING FEMALE HEX DRIVER (PLEASE SEE PHOTO 2 AND 3). THE PHOTOS SHOW THE REPRODUCED SITUATION OF THE DEFECT BY USING SALES SAMPLE. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS 5 MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7096966 ↗

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-0490-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
• 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-0488-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
• 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-0487-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
• Z-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100