GLOBAL UNITE 1100-20-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295004233), received between Aug 30, 2018 and Dec 5, 2025 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD FRACTURED HER HUMERUS, CAUSING THE SURGEON TO WANT TO CONVERT THE ORIGINAL ANATOMIC SHOULDER TO A REVERSE. NO KNOWN INFECTION WAS PRESENT. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 23727892 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHOULDER JOINT REPLACEMENT FOR A PROXIMAL HUMERAL FRACTURE WAS PERFORMED. AFTER THE SURGERY, THE PATIENT WAS INFECTED WITH MRSA, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. IN THE REVISION SURGERY, THE HEAD AND COLLAR WERE REMOVED AND REPLACED WITH THE SAME SIZE ONES. AFTER THE REPLACEMENT, THE DEBRIDEMENT WAS DONE, AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE EVENT WAS NOT RELATED TO THE PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22902395 ↗
• 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 13042674 ↗
• MalfunctionJul 30, 2019Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE SURGEON WAS USING A GLOBAL UNITE SHOULDER SYSTEM TO TREAT A HUMERAL FRACTURE. HE WANTED TO USE THE UNITE FRACTURE SYSTEM WITH THE SUTURE COLLAR. THE SET WAS NOT STERILE AND WE HAD TO USE THE IMPLANTS USING THE UNITE COMMON AND ANATOMIC INSTRUMENT SET. WE WERE MISSING THE SUTURE COLLAR INTERSOWE USED A FEMORAL HEAD IMPACTOR WORKING AROUND THE PERIMETER OF THE HUMERAL MORSE TAPER TO SEAT THE COLLAR. THE COLLAR WAS CHECKED FOR STABILITY BY THE SURGEON AND HE FELT IT WAS SECURE. UTILIZING THE IMPACTION STAND FOR BOTH SEATING THE COLLAR AND THE HEAD BOTH PIECES WERE SECURED. THE GLOBAL UNITE FRACTURE CONSTRUCT IN A PRE ASSEMBLED STATE WAS LOOSE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8840983 ↗
• 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 7832153 ↗

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-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-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
• 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