DJO SURGICAL 804-06-013Recalls & reported problems
Djo, LLC · RSP GLENOID HALF-MOON REAMER, SMALL · 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 00888912148764), received between Dec 5, 2019 and Feb 14, 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
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2022Dull, Blunt
INSTRUMENT FAILURE - BLUNT INSTRUMENTATION PREVENTING GLENOID BONE PREPARATION TO RECEIVE THE REVERSE SHOULDER PROSTHESIS BASEPLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13522883 ↗MalfunctionDec 28, 2020Dull, Blunt
INSTRUMENT FAILURE - DUE TO 1/2 MOON REAMER BLUNT.
Patient problems: Insufficient Information
MAUDE report 11084111 ↗MalfunctionDec 5, 2019Physical Resistance/Sticking
INSTRUMENT FAILURE - THE GLENOSPHERE REMOVAL TOOL, WE WILL NOT BE GETTING BACK AS IT WENT TO A LAB FOR CULTURE TESTING ON AN INFECTED PATIENT. THE REMOVAL TOOL BECAME STUCK IN THE IMPLANT. THE REAMER WE CAN SEND BACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9418035 ↗
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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