RECLAIM 2975-31-105Recalls & reported problems
Depuy (Ireland) · RECLAIM PROXIMAL TRIAL SHAFT INSERTER · 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 10603295156383), received between Aug 31, 2017 and May 7, 2026 — 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
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL SHAFT INSERTER WAS NOT GRASPING PROPERLY. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111465 ↗MalfunctionAug 21, 2018Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENT GOT BENT DURING SURGERY AND IS NOW DEFORMED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7800840 ↗MalfunctionAug 31, 2017Break; Break
IT WAS REPORTED THAT PROXIMAL TRIAL SHAFT INSERTER BROKE IN TWO PIECES DURING SURGERY AND WAS DISCARDED BY THE HOSPITAL.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 6834466 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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