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GLOBAL APG+ 2236-00-001Recalls & reported problems

Depuy (Ireland) · GLOBAL APG+ SIZER PIN GUIDE SIZE 40 +0mm · Class 1

All models of GLOBAL APG+ (34)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
21
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295105688), received between Jun 29, 2017 and Mar 31, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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.

Reports received per month

Nov 2023: 3 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break8
  • Device-Device Incompatibility8
  • Naturally Worn8
  • Scratched Material4
  • Material Twisted/Bent2
  • Material Deformation1
  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions11
  • Insufficient Information4
  • No Consequences Or Impact To Patient4
  • No Information2

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 31, 2026Break

    IT WAS REPORTED THAT DURING PRE-SURGERY SET-UP IT WAS OBSERVED THAT THE APG GLENOID SIZER 40MM +0 VERSION WAS BROKEN ON THE CONSIGNMENT TRAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24741891 ↗
  • MalfunctionJul 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE GLENOID PIN GUIDE WOULD NOT STAY ON HANDLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22419780 ↗
  • MalfunctionNov 1, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. THE 40 +0 PIN GUIDE WAS DAMAGED DURING NORMAL USE, AND THE PIN WON¿T GO THROUGH THE GUIDE.

    Patient problems: Insufficient Information

    MAUDE report 20586663 ↗
  • MalfunctionJan 24, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

    THE ITEMS ARE CRACKED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18574427 ↗
  • MalfunctionJan 10, 2024Naturally Worn; Naturally Worn

    WEAR AND TEAR ON SIZER PIN GUIDES. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18484894 ↗
  • MalfunctionNov 21, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

    IT WAS REPORTED THAT GUIDES HAVE GOUGES OUT OF THEM AND ARE NOT SMOOTH. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST, TRUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18181862 ↗
  • MalfunctionNov 16, 2023Break; Break

    GLOBAL ICON AP TRAY ZNAUE0019 WAS SENT, HOSPITAL NOTICED BASE OF GUIDE PIN 223600001 WAS SNAPPED OFF. THIS OCCURRED ON CHECK IN AND ALLOWED TIME FOR A REPLACEMENT TRAY TO BE SENT. NO IMPACT TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18147924 ↗
  • MalfunctionNov 16, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

    IT WAS REPORTED THAT THE GLOBAL UNITE SIZER PIN GUIDES +0 ARE A WORN DOWN AND BEAT UP. THEY NEED TO BE REPLACED. THERE WERE DINGS AND SCRATCHES ON THE SIZERS. SURGICAL DELAY UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 18147319 ↗
  • MalfunctionJul 21, 2023Scratched Material; Scratched Material

    ADDITIONAL INFORMATION RECEIVED: 1. THE TEETH ON THE SCREWDRIVER BROKE OFF AND WE USED ANOTHER ONE FROM A SECOND KIT. 2. THIS INSTRUMENT WAS SCRATCHED UP TOO BADLY TO BE RESTERILIZED. 3. THIS PRODUCT WAS SCRATCHED UP FROM YEARS OF USE AND NOT FIT FOR RESTERILIZATION

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17370184 ↗
  • MalfunctionJul 20, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

    IN SURGERY ON FRIDAY (B)(6) 2023 THE SURGEON REPORTED THE PERIPHERAL DRILL BITS WERE BLUNT AND THE APG+ SIZER GUIDES WERE SLIGHTLY LOOSE ON THE HANDLE DUE TO WEAR. NO DELAY TO THE OPERATION AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS A HEAVILY USED KIT AND IS GENERAL WEAR AND TEAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17365213 ↗
  • MalfunctionAug 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT SIZING DISC WON¿T STAY ON THE HANDLE. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15277980 ↗
  • MalfunctionJun 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

    IT WAS REPORTED THAT THE DEVICE HAS WORN DOWN AND WOULD NOT STAY 40+0 AND S2+0 APG PIN POSITIONERS WERE IN THE CURVED APG HANDLE. SURGERY WAS NOT DELAYED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14648674 ↗
  • MalfunctionJan 27, 2022Break; Break

    SIZER PIN GUIDE SNAPPED IN HALF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13370974 ↗
  • MalfunctionMar 23, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

    IT WAS REPORTED THAT DURING TOTAL SHOULDER IT WAS NOTED THAT THE 40 AND 44 SIZERS WERE NOT HOLDING ON THE GUIDE DUE TO WEAR. A SECOND SET WAS OPENED AND THESE WERE ALSO WORN. THIS CAUSED A 5-MINUTE DELAY TO SURGERY.

    Patient problems: Insufficient Information

    MAUDE report 11553545 ↗
  • MalfunctionMar 23, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

    IT WAS REPORTED THAT DURING TOTAL SHOULDER IT WAS NOTED THAT THE 40 AND 44 SIZERS WERE NOT HOLDING ON THE GUIDE DUE TO WEAR. A SECOND SET WAS OPENED AND THESE WERE ALSO WORN. THIS CAUSED A 5-MINUTE DELAY TO SURGERY.

    Patient problems: Insufficient Information

    MAUDE report 11553543 ↗
  • MalfunctionOct 23, 2018Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE GUIDES IN THE SET NEED TO BE REPLACED BECAUSE THEY DO NOT LOCK ONTO THE HANDLE ANYMORE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7995591 ↗
  • MalfunctionMar 20, 2018Break; Break

    IT WAS REPORTED THAT THE APG + SIZER PIN GUIDE WAS FOUND BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7352377 ↗
  • MalfunctionDec 29, 2017Break; Break

    THE GLENOID SIZER PIN GUIDE (40+0) WAS BROKEN. IT HAS TWO TABS WHICH COMPRESS/EXPAND TO ATTACH A HANDLE AND ONE IS PARTIALLY BROKEN AWAY MEANING THE HANDLE CAN NO LONGER BE ATTACHED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7153954 ↗
  • MalfunctionDec 3, 2017Break; Break

    IT WAS REPORTED THAT THE GUIDE PIN BROKE DURING TRIAL, THE PEG SEPARATED FROM THE MAIN BODY. USED THE 44 PIN INSTEAD. THE OLD PIN WAS DISCARDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7078152 ↗
  • MalfunctionOct 26, 2017Break; Break

    IT WAS REPORTED THAT THE INSTRUMENT GUIDE BROKE DURING SET UP WHILE ASSEMBLING.

    Patient problems: No Information

    MAUDE report 6979039 ↗
  • MalfunctionJun 29, 2017Break; Break

    IT WAS REPORTED THAT THE SIZING DISKS WAS BROKEN.

    Patient problems: No Information

    MAUDE report 6678341 ↗

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