RECLAIM 2976-20-000Recalls & reported problems
Depuy (Ireland) · RECLAIM CLEAR OUT REAMER · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295443568), received between Dec 5, 2018 and Jan 5, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn2
- Break1
- Failure to Cut1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Bone Fracture(s)1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Break
IT WAS REPORTED THAT DURING HIP SURGERY, THE CLEAR OUT REAMER WAS DIFFICULT TO CHUCK UP AND HAS NOTICEABLE DAMAGE ON THE TIP. THE SLAP HAMMER BROKE OFF COMPLETELY WHEN WE TRIED TO REMOVE THE DISTAL STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961846 ↗MalfunctionDec 8, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CLEAR OUT REAMERS NEED TO BE REPLACED DUE TO EXTENSIVE WEAR TO THE FLUTES. THIS WAS NOTICED DURING SURGERY. BOTH NEED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12961637 ↗MalfunctionDec 8, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CLEAR OUT REAMERS NEED TO BE REPLACED DUE TO EXTENSIVE WEAR TO THE FLUTES. THIS WAS NOTICED DURING SURGERY. BOTH NEED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12961593 ↗MalfunctionOct 15, 2020Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO CONSEQUENCE OF DELAY, THE DELAY WAS ABOUT 5 MINUTES TRYING TO GET THE REAMERS TO ENTER THE CANAL.
Patient problems: No Code Available
MAUDE report 10685877 ↗InjuryDec 5, 2018Fracture; Fracture
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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