GLOBAL AP 2130-01-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295090656), received between May 1, 2018 and Jul 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE HEAD DISTRACTOR WAS A BIT DAMAGED ON ITS PRONGS. PARTS OF THE METAL PRONGS WERE SPIKING OFF. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315129 ↗
• MalfunctionSep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTRUMENT/S WAS REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593004 ↗
• MalfunctionMay 1, 2018Break; Break

  PROCEDURE WAS HEMI SHOULDER ARTHROPLASTY CONVERTING TO A TOTAL REVERSE SHOULDER. INSTRUMENTS BEING USED WAS BEING PLACED UNDER THE COLLAR IMPLANT AND THE TIP BROKE OFF THE INSTRUMENT AND THE PIECE WAS RETRIEVED FROM SHOULDER. A LIKE INSTRUMENT WAS BEING USED AND ONE OF THE TINES OF THE INSTRUMENT BECAME BENT. AT THIS POINT THE COLLAR WAS SUCCESSFULLY REMOVED FROM THE HUMERAL IMPLANT. PATIENT CONSEQUENCE? :NO. PATIENT CONSEQUENCE DESCRIPTION: BROKE FROM INSTRUMENT WAS FOUND AND REMOVED FROM TABLE. ACTION TAKEN FOR PROCEDURE: LIKE INSTRUMENT WAS USED BUT IT BENT THE INSTRUMENT BUT AT THAT POINT THE SURGEON HAD ACHIEVED REMOVAL OF THE IMPLANT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable

  MAUDE report 7476281 ↗