RECLAIM 44-00000-45Recalls & reported problems
Depuy (Ireland) · RECLAIM MONOBLOC REVISION HIP SYSTEM NECK TRIAL HIGH OFFSET · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295537236), received between May 30, 2025 and Apr 10, 2026 — classified as 5 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
- Device-Device Incompatibility2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT RECLAIM MONOBLOC HIGH OFFSET NECK SEGMENT IS STRIPPED. THE INSTRUMENT WILL NOT SCREW INTO THE DISTAL REAMER PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845026 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT THE ROCKING RING BROKEN OFF NECK TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203323 ↗MalfunctionSep 4, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DOCTOR COMPLAINED THAT THE RECLAIM MONOBLOC NECK TRIAL HO WAS SLIPPING AND NOT HOLDING ON THE REAMER DURING TRIAL REDUCTION AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964036 ↗MalfunctionJun 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP. DURING TRIALING, THE NECK TRIAL RETAINING C-CLIP BENT AND WAS NOT ABLE TO BE USED. ALL PIECES ARE PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22222756 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL NECK WAS BROKEN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113241 ↗
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- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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