GLOBAL APG+ 2236-00-023Recalls & reported problems
Depuy (Ireland) · GLOBAL APG+ BONE GRAFT APPLICATOR · Class 1
All models of GLOBAL APG+ (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295105909), received between Mar 1, 2021 and Dec 5, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Contamination /Decontamination Problem1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BONE APPLICATOR IN ANCHOR PEG GLENOID (APG) SYSTEM TRAY WAS BECOMING LOOSE. THERE WAS NO DELAY TO SURGERY OCCURRED. SURGERY WAS COMPLETED WITH NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733360 ↗MalfunctionJun 12, 2024Break; Break
IT WAS REPORTED THAT THE LATCH HOLDING THE TWO PIECES TOGETHER BROKE, DISCONNECTING THE TWO PIECES.
Patient problems: Insufficient Information
MAUDE report 19524338 ↗MalfunctionMar 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING THE OPERATION ONE OF THE KITS 1028 WAS FOUND TO HAVE A FAIR BIT OF THE PREVIOUS PATIENT STILL REMAINING WITHIN IT. IT HAD NOT BEEN CLEANED PRIOR TO STERILISATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13665984 ↗MalfunctionMar 1, 2021Break; Break
IT WAS REPORTED THAT THE SURGEON WENT TO PACT BONE GRAFT ONTO IMPLANT AND THE PIN BROKE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11395529 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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