DJO SURGICAL 804-06-012Recalls & reported problems
Djo, LLC · RSP GLENOID HALF-MOON REAMER, STARTER · Class 1
All models of DJO SURGICAL (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912148757), received between Sep 9, 2021 and Feb 24, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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.
Most reported problems
Device problems
- Dull, Blunt2
- Break1
- Naturally Worn1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2022Dull, Blunt
INSTRUMENT FAILURE: SURGEON COMPLAINING OF INEFFECTIVE GLENOID REAMING WITH THESE INSTRUMENTS. CHRONIC ISSUE AS THE INSTRUMENTS WERE BLUNT. THE BLUNTED BLADE DOES NOT REAM BONE. POOR DESIGN AND BLUNT BLADES.
Patient problems: Insufficient Information
MAUDE report 13590888 ↗MalfunctionFeb 15, 2022Dull, Blunt
INSTRUMENT FAILURE - BLUNT INSTRUMENTATION WHEN REAMING GLENOID BONE. HAD TO RESORT TO FULL MOON REAMER BUT WAS NOT HAPPY, AS ACCESS WAS DIFFICULT.
Patient problems: Insufficient Information
MAUDE report 13534211 ↗MalfunctionSep 9, 2021Break; Naturally Worn
COMPLAINT - GLENOID REAMER'S CUTTING EDGE WAS DAMAGED DURING USE. THE PATIENT HAD A METAL ANCHOR FROM A PREVIOUS SURGERY THAT DULLED THE INSTRUMENT BEYOND REGULAR WEAR AND TEAR.
Patient problems: Insufficient Information
MAUDE report 12448934 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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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