GLOBAL APG+ 2236-00-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295105718), received between Jun 29, 2017 and Sep 22, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Break” (26 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that during an anatomic shoulder replacement procedure when using a Size 52 APG+ it was observed that the Sizing template broke where the template attached to handle when the surgeon was placing it onto the guide handle. No patient harm or involvement. No surgical delay. Surgeon used smaller template to proceed with case.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852373 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DID NOT HAPPEN IN SURGERY. POST ON APG DRILL GUIDE WAS DAMAGED/WORM, DOES NOT STAY ON HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575543 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT 52 +0 PIN GUIDE WON'T HOLD WELL IN HANDLE. NO DELAY TO SURGERY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298279 ↗
• MalfunctionMar 20, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PRODUCT DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651037 ↗
• MalfunctionApr 8, 2024Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  NOTICED THAT THE BACK OF THE PLASTIC GUIDE WAS BROKEN WHEN TRAYS WERE OPENED. WOULD NOT FIT ONTO GUIDE HANDLE DUE TO DEFORMITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067267 ↗
• MalfunctionFeb 19, 2024Break; Break

  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 18730538 ↗
• MalfunctionJan 9, 2024Crack; Scratched Material; Crack; Scratched Material

  CRACKED AND DAMAGED SIZER PIN GUIDE. 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 18475515 ↗
• MalfunctionDec 21, 2023Device-Device Incompatibility; Material Deformation; Naturally Worn; Scratched Material; Device-Device Incompatibility; Material Deformation; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. -WORN AWAY - THE HEX COMPONENTS OF THE GUIDE HAVE BEEN BURRED OUT SO THAT THEY NO LONGER FIT ONTO THE HEX COMPONENT OF THE GUIDE HANDLE. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO C. CAN YOU CONFIRM THE EVENT DATE ONCE? -UNSURE - GRADUAL WEARING OVER TIME SO NO SPECIFIC DATE, ONLY INFORMED DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379871 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT THE SIZER PIN GUIDE HAS A CHIPPED POST. 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 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 18236606 ↗
• 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 18147321 ↗
• MalfunctionNov 15, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT ON RETURN INSPECTION THE INSTRUMENT BROKE, THE END WHICH PROTRUDES SNAPPED. IT ALSO STATES THAT THE FRAGMENT WAS NOT LOCATED WITHIN THE LOAN SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145544 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT UPON REMOVING THE APG+ PIN GUIDE FROM THE PATIENT, AFTER POSITIONING THE GUIDE WIRE, THE PROTRUDING PLASTIC PART OF THE GUIDE WHICH SITS INTO THE CURVED HANDLE DRIVER SHEARED OFF FROM THE OVAL PART. THE SMALL PART REMAINED IN THE CURVED HANDLE DRIVER AND THE SURGEON REMOVED IT ON THE BACK TABLE. NO PART WAS LEFT IN THE PATIENT AND THERE WAS NO DELAY TO THE PROCEDURE AS THE GUIDE WIRE HAD BEEN POSITIONED IN THE GLENOID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316366 ↗
• MalfunctionJun 6, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT GLENOID SIZER GUIDES FROM TRAY WERE CRACKED AND DAMAGED DURING CASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073061 ↗
• MalfunctionJan 26, 2023Break; Crack; Break; Crack

  FRAGMENTS GENERATED WERE OVER ON NURSING STATION AND DID NOT AT ANY POINT ENTER THE PATIENT. THERE WAS 1 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245894 ↗
• MalfunctionDec 2, 2022Break; Break

  IT WAS REPORTED THAT PIN GUIDE BROKE INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904272 ↗
• MalfunctionNov 30, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE 52 +0 PEG WORN DOWN. DOES NOT ATTACHED TO HANDLE PROPERLY, NO PIECES. 48/52/56 REAMERS WAS DULL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888185 ↗
• MalfunctionOct 1, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  INTER-OPERATIVELY DURING A TOTAL SHOULDER REPLACEMENT, THE SURGEON USED THE APG+ 52MM SIZER PIN GUIDE (223600004) ON THE CURVED HANDLE (22300023). AFTER PLACING THE METAGLENE PIN, HE WAS NOT HAPPY WITH THE VERSION SO AS HE PULLED BACK ON THE HANDLE (ON AN ANGLE AND NOT IN LINE WITH PIN) AND PART OF THE GUIDE GOT CAUGHT AND DID NOT COME OUT. A KOCKER FORCEP WAS USED TO REMOVE THE GUIDE. IT WAS THEN NOTICED THAT PART OF THE HEXAGONAL PROMINENCE ON THE GUIDE WAS MISSING AND WAS FOUND IN THE CURVED HANDLE. THE BROKEN PIECE AND REMAINDER OF THE GUIDE WERE KEPT SEPARATE FOR DECONTAMINATION AND RETURN TO QLD WAREHOUSE WITH LOAN SET. SURGEON USED THE APG+ 52MM +3 SIZER PIN GUIDE TO CORRECT VERSION OF METAGLENE PIN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525979 ↗
• 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 15277964 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT THE TEETH ON PATELLA CUT GUIDE ARE VERY DULL, IT WILL NOT STAY ON THE PATELLA. THE POST ON THE 52 0 APP SIZER HAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075083 ↗
• MalfunctionJul 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE APG+ CURVED HANDLE DID NOT HOLD SIZER PIN GUIDES DURING CASE. ALSO SIZER PIN GUIDES 52+0 WAS WORN DOWN AND WOULD NOT STAY ON THE HANDLE. ALL INSTRUMENTS WERE DISPOSED OF BEFORE BEING ABLE TO RETURN BACK. ALL PIECES WERE RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14931187 ↗
• MalfunctionJul 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE APG+ CURVED HANDLE DID NOT HOLD SIZER PIN GUIDES DURING CASE. ALSO SIZER PIN GUIDES 52+0 WAS WORN DOWN AND WOULD NOT STAY ON THE HANDLE. ALL INSTRUMENTS WERE DISPOSED OF BEFORE BEING ABLE TO RETURN BACK. ALL PIECES WERE RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14931086 ↗
• 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 14648599 ↗
• MalfunctionFeb 23, 2022Break; Break

  BROACH STICKS TO BROACH HANDLE. GUIDE IS BROKEN. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586568 ↗
• MalfunctionNov 29, 2021Crack; Crack

  IT WAS REPORTED THAT THE GLENOID PIN GUIDE WAS STARTING TO CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12881846 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT THE PLASTIC SIZING GUIDE 52+0 FROM THE APG+ TOP TRAY BROKE DURING THE CASE. PLASTIC PIECES RETRIEVED AND DISPOSED OF. SIZER PLACED BACK IN TRAY. NO EFFECT ON SURGERY TIME. PATIENT OUTCOME THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487860 ↗