GLOBAL STEPTECH APG 2230-00-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295102892), received between Oct 19, 2018 and Nov 2, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Break; Crack; Break; Crack

  A PART OF THE ITEM HAS CRACKED AND BROKEN OFF. 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 18057242 ↗
• MalfunctionDec 15, 2022Break; Break

  IT WAS REPORTED THAT THE BACK OF THE 56 PLUS 5 TRIAL GLENOID BROKE OFF. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992956 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT WHILE PUTTING IN THE GUIDE WIRE AND WHEN HE WENT TO PULL THE TRAIL OFF THE TIP OF THE TRIAL BROKE IN THE HANDLE. ALL PARTS WERE REMOVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820305 ↗
• MalfunctionJun 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTACHMENT PEG WAS SO WORN DOWN FROM BEING USED, IT WOULD NOT STAY ATTACHED TO THE HANDLE. EVERY TIME THE DOCTOR PUT IT IN THE SHOULDER, IT FELL OFF THE HANDLES. NO PARTS BROKE IN PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734667 ↗
• MalfunctionOct 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDE IS NOT HOLDING ONTO THE INSERTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985565 ↗