GLOBAL AP 2130-20-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295090809), received between May 10, 2018 and Jan 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Material Deformation

  IT WAS REPORTED THAT THE 3.2MM OSTEOTOMY GUIDE PIN LONG BENT IN USE DURING SURGERY. NO DELAY TO SURGERY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172890 ↗
• MalfunctionApr 29, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT OCCURRED DURING SURGERY. NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926382 ↗
• MalfunctionApr 29, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT OCCURRED DURING SURGERY. NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926363 ↗
• MalfunctionApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THIS INSTRUMENT IS COMPOSED OF 1 PART EACH. 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. ADDITIONAL EVENT INFORMATION: THE PHOTO INVESTIGATION REVEALED THAT ' 213020000, GL AP 3.2MM OSTEO GD PIN LONG¿ HAD SCRATCHES ON THE SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121851 ↗
• MalfunctionApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THIS INSTRUMENT IS COMPOSED OF 1 PART EACH. 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. ADDITIONAL EVENT INFORMATION THE PHOTO INVESTIGATION REVEALED THAT 213020000, GL AP 3.2MM OSTEO GD PIN LONG¿ HAD SCRATCHES ON THE SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121840 ↗
• MalfunctionNov 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GUIDE PIN WAS FOUND BENT IN SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895772 ↗
• MalfunctionMay 10, 2018Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE ITEM ARRIVED AT THE OFFICE, THE PACKAGE WHICH SHOULD HAVE HELD A GLOBAL OSTEOTOME GUIDE PIN, WAS EMPTY. A HOSPITAL AND SURGERY NOT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503361 ↗