RECLAIM 34-185-0016Recalls & reported problems
Depuy (Ireland) · RECLAIM MONOBLOC – REVISION HIP SYSTEM MONOBLOC DISTAL REAMER STANDARD 16 · Class 1
All models of RECLAIM (149)
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 10603295536116), received between Oct 7, 2024 and May 30, 2025 — 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. 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
- Break1
- Corroded1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WERE TWO COLD WELDED INSTRUMENTS DURING A CASE. IT DID NOT AFFECT PATIENT CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114649 ↗MalfunctionJan 15, 2025Corroded; Corroded
IT WAS REPORTED THAT THE SPD REFUSED TO PROCESS THE ITEM DUE TO CORROSION/BLEMISH/RUST ON THE REAMER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158852 ↗MalfunctionOct 7, 2024Break; Break
IT WAS REPORTED THAT THE 16 MM STANDARD DISTAL REAMER SPLINES WERE DAMAGED WHEN REMOVING THE TRIAL NECK FROM THE REAMER. THE 51/28 MOBILE BEARING HEAD TRIAL WAS DROPPED ON THE FLOOR AND LOST BY HOSPITAL STAFF. ALSO, THE DEPTH GAUGE WAS ACCIDENTLY DAMAGED AND BENT. NONE OF THESE ISSUES DELAYED SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392039 ↗
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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