GLOBAL UNITE 1100-52-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295004738), received between Feb 16, 2018 and Jan 22, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Disconnection” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM ANATOMIC TO REVERSE DUE TO ROTATOR CUFF FAILING OVERTIME. NO FURTHER INFORMATION AVAILABLE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24149638 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY DONE IN MARCH. THE PATIENT WAS COMPLAINING OF PAIN IN ARM AND LACK OF EXTERNAL ROTATION AND UPWARD MOBILITY IN OPERATIVE SHOULDER. SURGEON DECIDED TO DOWN SIZE HEAD TO LIMIT STRESS ON SUBSCAP. ALSO DID A SUBSCAP REPAIR. AFFECTED SIDE: RIGHT SHOULDER.

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

  MAUDE report 23094425 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF ANATOMIC TO REVERSE TOTAL SHOULDER DUE TO ROTATOR CUFF FAILURE. STAFF WERE UNSURE OF THE IMPLANTATION DATE AND CANNOT READ THE LOT NUMBER OFF OF IMPLANT. THERE WAS NO IMPLANT FAILURE, NO LOOSENING, NO SURGEON COMPLAINTS, NO DELAY AND NO ADVERSE EVENT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21994022 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S ROTATOR CUFF BECAME UNSTABLE. SURGEON REVISED FROM AN ANATOMIC TO A REVERSE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21257061 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO THE SURGEON SUSPECTS INFECTION AND REMOVED COMPONENTS TO WAIT 6 WEEKS TO RETURN TO IMPLANT A REVERSE TOTAL SHOULDER. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15084421 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO NO MOTION IN THE RIGHT SHOULDER. A SURGERY WAS PLANED TO REMOVE THE ADHESIONS AND IMPLANT A SMALLER HEAD. CULTURES WERE SENT TO RULE OUT INFECTION. RELEASES WERE PERFORMED AND ADHESIONS WERE REMOVED. RANGE OF MOTION WAS OBSERVED TO BE INCREASED FROM ZERO TO APPROXIMATELY 80 DEGREES. BUT, IT WAS ALSO DISCOVERED THAT THE GLENOID COMPONENT WAS LOOSE. THE DECISION WAS MADE TO CONVERT TO A HEMI SHOULDER ARTHROPLASTY AND GRAFT THE GLENOID. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 14625541 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHOULDER IS UNSTABLE/TENSIONED. HUMERAL HEAD EXCHANGE PERFORMED. NO LOOSENING AND NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 11405170 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT IS BEING REVISED FOR CHRONIC PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 11247546 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN DUE TO INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

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

  MAUDE report 10906036 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD THEIR INDEX HEMI REVISED TO AN A TOTAL SHOULDER ARTHROPLASTY FOR PAIN. HEAD AND TAPE REMOVED; APG+ IMPLANTED ALONG WITH NEW HEAD AND 135 DEGREE TAPER. DOI: (B)(6) 2020; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9938874 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL SHOULDER DONE BY THE SURGEON AT (B)(6) HOSPITAL SEVERAL YEARS AGO. 4 MONTHS AGO HE CAME TO THE SURGEON AT (B)(6) FOR SHOULDER DISCOMFORT. THE SURGEON DID ARTHROSCOPY SURGERY TO REMOVE THE GLENOID. THE DEPUY REPS WERE UNAWARE OF THAT PROCEDURE. ON (B)(6) 2020, THE PATIENT CAME BACK TO HAVE A NEW GLENOID IMPLANTED AND A HEAD EXCHANGE. DOI: 4 MONTHS AGO (GLENOID), DOI: SEVERAL YEARS AGO (HEAD), DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9727334 ↗
• InjuryAug 13, 2018Disconnection; Disconnection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLOBAL UNITE HEAD 52X18 ECC FROM THE STEM.

  Patient problems: No Code Available

  MAUDE report 7776463 ↗
• InjuryFeb 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS. DOI 2015; DOR (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Osteolysis

  MAUDE report 7276252 ↗

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-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-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-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