GLOBAL STEPTECH APG 2230-00-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295102854), received between Jul 9, 2018 and Jun 17, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. WAS THERE ANY REPORTED PATIENT OR USER HARM? UNKNOWN . WAS THERE A SIGNIFICANT DELAY? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532880 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT WHEN RESETTING THE INSTRUMENTS THE GLENOID SIZER TRIAL HAD THE BACK SIDE BROKEN OFF. IT WORKED FINE IN THE CASE SO IT BROKE DURING THE CASE BUT IN STERILE PROCESSING AFTER.

  Patient problems: Insufficient Information

  MAUDE report 21071356 ↗
• MalfunctionOct 3, 2023Crack; Crack

  IT WAS REPORTER THAT PHOTO INVESTIGATION REVEALED THAT THE DEVICE ST APG SIZER PIN GUIDE 52+3 HAD A CRACKED POST AND SCRATCHES ON THE SURFACE. IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (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 17861095 ↗
• MalfunctionAug 25, 2022Break; Break

  GLENOID GUIDE BROKE OFF INSIDE INSERTER HANDLE. SURGEON WAS FINISHED USING DEVICE SO IT DIDN¿T IMPACT CASE BUT RENDERED THE HANDLE AND 52+3 GUIDE UNUSABLE FOR FUTURE CASES. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15295046 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT THE CONNECTION POST BROKE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14217998 ↗
• MalfunctionOct 26, 2021Break; Break

  IT WAS REPORTED THAT THE APG+ SIZER DISK/PIN GUIDE BROKE BEFORE USING THE INSTRUMENT AND ALL PIECES WERE ACCOUNTED FOR. THIS DID NOT SLOW DOWN THE SURGERY AND THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698774 ↗
• MalfunctionSep 29, 2021Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED BACK SIDE OF THE PIN GUIDE WHERE +3 INDENTATION WAS SCRATCHED, CHIPPED AND SEVERELY WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548733 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED THAT THE ST APG SIZER PIN GUIDE 52+3 WAS CHIPPED AND WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401621 ↗
• MalfunctionJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT CLEAR SIZERS DO NOT LOCK ONTO HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7670099 ↗