RECLAIM 44-00000-31Recalls & reported problems
Depuy (Ireland) · RECLAIM MONOBLOC REVISION HIP SYSTEM NON-RETAINING STEM IMPACTOR · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295537243), received between Mar 18, 2025 and May 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025No Apparent Adverse Event; No Apparent Adverse Event
INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. DURING DEVICE RECEIPT AND INVESTIGATION IT WAS DETERMINED THE DEVICE WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22018615 ↗MalfunctionMar 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT TWO INSTRUMENTS WOULD NOT DISCONNECT. THE EVENT DID NOT HAPPEN IN SURGERY. THERE WAS NO SURGICAL DELAY; NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635197 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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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