GLOBAL UNITE 1100-48-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295004615), received between Jan 5, 2018 and Feb 19, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANATOMIC TO REVERSE REVISION NOT DUE TO IMPLANT FAILURE BUT TO ROTATOR CUFF WEAR. NO FURTHER INFORMATION KNOWN AT THIS TIME. PRODUCT LOTS ARE UNTRACEABLE THROUGH OPTIMIZE DUE TO LACK OF PRIOR CASE DGR. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24389180 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS' ROTATOR CUFF FAILED AND NEEDED CONVERSION TO A REVERSE DELTA XTEND SHOULDER. HUMERAL HEAD IMPLANT AND PROX BODY IMPLANT WERE RETRIEVED WITH NO DEFORMITIES, DAMAGE, OR LOSS OF FIXATION. NO OTHER INFORMATION IS KNOWN AT THIS TIME. LOT NUMBERS ARE UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23920807 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUBSCAP FAILURE. IT WAS PUT IN REVERSE. THIS WAS A SUBSCAP FAILURE NOT CEMENT ISSUE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23401887 ↗
• InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A GLOBAL ANATOMIC IMPLANTED ON (B)(6) 2019. POST OPERATIVELY THE HEAD DISLODGED FROM PROXIMAL BODY WHILST PATIENT WAS IN BED. GLOBAL UNITE ANATOMIC ANCHOR PEG GLENOID, GLOBAL UNITE HEAD, AND GLOBAL UNITE ANATOMIC PROXIMAL BODY REMOVED. REPLACED WITH DELTA X-TEND REVERSE IMPLANTS. REVISION OCCURRED (B)(6) 2025 SIGNIFICANT METALLOSIS IN PATIENT WAS NOTICED AND IMPLANTS WILL BE CLEANED BY THE HOSPITAL TO BE SENT FOR INVESTIGATION.

  Patient problems: Foreign Body Reaction

  MAUDE report 22714636 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN TO REVISE AN ANATOMIC TSA TO A REVERSE TSA. PATIENT HAD A FAILED ROTATOR CUFF WHICH REQUIRED REVISION NO IMPLANT COMPLICATIONS. NO PATIENT DELAY. NO HARM TO PATIENT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22151033 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CONVERSION TO REVERSE SHOULDER DUE TO ROTATOR CUFF FAILURE. NO IMPLANT LOOSENING OR FAILURE. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER .

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21892299 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN SHOULDER REGION AFTER SHOULDER REPLACEMENT; CHRONIC PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2020. (RIGHT SHOULDER). TREATMENT: INITIAL WORK UP FOR INFECTION WITH BLOOD WORK.

  Patient problems: Loss of Range of Motion; Nerve Damage; Numbness; Pain; Paresthesia; Unspecified Infection

  MAUDE report 15951432 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS SHOULDER REPLACED BY SURGEON SOMETIME AGO .THE PATIENT HAD A GLOBAL UNITE CONSTRUCT IMPLANTED. THE PATIENT DID WELL INITIALLY BUT INJURED HIS ROTATOR CUFF AND LOST ROM OVER TIME. IT WAS DECIDED THAT SURGEON WOULD CONVERT THE ANATOMIC CONSTRUCT TO A REVERSE CONSTRUCT. THE APG , HUMERAL HEAD, AND PROXIMAL BODY WERE EXPLANTED DURING THE REVISION SURGERY. THE STEM WAS LEFT IN SITU AND A DELTA REVERSE CONSTRUCT WAS IMPLANTED. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Loss of Range of Motion; Unspecified Musculoskeletal problem

  MAUDE report 13667212 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOW GRADE INFECTION WHICH CAUSED STEM TO MOVE INTO VALGUS. DOI: (B)(6) 2017. DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 12953490 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER PAIN. SURGEON DETERMINED THE SHOULDER HAD SOME SORT OF INFECTION THAT REQUIRED IT TO BE WASHED OUT. WHILE THE SURGEON WAS IN THE JOINT SURGEON DECIDED IT BEST TO REMOVE THE TAPER AND HEAD SO HE COULD REPLACE THEM. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12729070 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 12229379 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS LOGGED TO CAPTURE THE REVISION MENTIONED IN (B)(4). THE BASE OF THE HANDLE OF THE STEM INSERTER BECAME LOOSE, ALLOWING IT TO SLIDE DOWN THE SHAFT OF THE INSERTER, AFTER THE SURGEON HAMMERED IT (IN THE CORRECT LOCATION) IN AN ATTEMPT TO REMOVE A STEM. THIS OCCURRED DURING A REVISION CASE WHERE A GLOBAL AP WAS BEING REMOVED. THE SURGEON WAS ABLE TO USE OTHER INSTRUMENTS WITHIN OUR SHOULDER EXTRACTION TRAYS TO SUCCESSFULLY REMOVE THE STEM AND COMPLETE THE OPERATION SUCCESSFULLY. THE REVISION WAS DUE TO THE PATIENT EXPERIENCING STIFFNESS DUE TO ARTHROFIBROSIS WITH A SMALL DEGREE OF CUFF DAMAGE. THE CAUSE OF THE REVISION DID NOT HAVE ANYTHING TO DO WITH THE IMPLANTS THEMSELVES. RIGHT SHOULDER.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscular Rigidity

  MAUDE report 11528218 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10680548 ↗
• InjuryMar 31, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  PATIENT WAS PRESENTED WITH PAIN IN ABDUCTION. DR. CARRIED OUT A SCAN OF THE EFFECTED SHOULDER AND PRINTED A 3D MODEL OF THE SHOULDER, HE DETERMINED THAT THE HUMERAL HEAD ECCENTRICITY WAS INCORRECTLY PLACED RESULTING IN THE GREATER TUBEROSITY ARTICULATING AGAINST THE SUBACROMIAL IN ABDUCTION. REVISION SURGERY WAS PREFORMED WITH HUMERAL HEAD REMOVED AND REPLACED WITH THE SAME SIZE ECC 48 X 18MM AND THE ECCENTRICITY CHANGED FROM INFERIOR MEDIAL POSITION TO SUPERIOR LATERAL POSITION. DR. CARRIED OUT RANGE OF MOTION TEST AND DETERMINED THAT GREATER TUBEROSITY NO LONGER ARTICULATED AGAINST THE SUBACROMIAL.

  Patient problems: No Code Available; Pain

  MAUDE report 9907848 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2014; DOR: (B)(6) 2019; LEFT SHOULDER.

  Patient problems: No Code Available; Pain

  MAUDE report 9191912 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID COMPONENT AT BONE TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 7955504 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES REVISION OF HUMERAL HEAD DUE TO PAIN. DOI: (B)(6) 2016; DOR: (B)(6) 2017; LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 7167145 ↗

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-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-0486-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
• 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-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-0484-2022 · Dec 7, 2021 · Terminated
  GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100