RECLAIM 2975-00-735Recalls & reported problems
Depuy (Ireland) · RECLAIM DISASSEMBLY TORQUE SHAFT 85mm · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295156116), received between Jan 23, 2020 and Jan 2, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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
- Device-Device Incompatibility5
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT 85MM TORQUE SHAFT AND PUSHROD WERE COLD WELDED (INSEPARABLE). THE PUSHROD TIP WAS BENT. THE BODY COLLET EXPANSION TIPS SHEARED OFF(FRAGMENTS WERE DISPOSED OF BY FACILITY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056462 ↗MalfunctionJun 27, 2022Device-Device Incompatibility; Device-Device Incompatibility
RECLAIM DISASSEMBLY TOOL WAS DAMAGED DURING PROXIMAL BODY EXTRACTION. THE TEETH WERE SHEERED OFF AND THREE PIECES ARE NOW STUCK TOGETHER. WE WERE UNABLE TO REMOVE PROXIMAL. ALL BROKEN PIECES WERE RETRIEVED AS FAR AS WE COULD TELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14828309 ↗MalfunctionJun 22, 2022Break; Break
INSTRUMENTS WERE DAMAGED DURING SURGERY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14773765 ↗MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility
INSTRUMENTS WOULD NOT COME APART AFTER SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13193572 ↗MalfunctionSep 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN TRYING TO BREAK THE TAPER OF THE STEM WITH THE DISASSEMBLY INSTRUMENTS, THE DISASSEMBLY COLLET BROKE, AND THE CAP, PUSH ROD AND TORQUE SHAFT ALL BECAME COLD WELDED INTO EACH OTHER. THEY OPENED AN ADDITIONAL SET, AND THE SAME THING OCCURRED WHERE THE COLLET BROKE, BUT THE OTHER ITEMS DIDN¿T COLD WELD THE SECOND TIME. WITH A SURGICAL DELAY OF 10 MINUTES.
Patient problems: Insufficient Information
MAUDE report 12491208 ↗MalfunctionJan 23, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE 85 MM ASSEMBLY ROD ADAPTOR IS MISSING LOCKING BEARINGS. 75MM, 85MM, AND CAP DO NOT SCREW TOGETHER PROPERLY, NEED NEW PRODUCTS FOUND DEFECTIVE DURING TRAINING IN OFFICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9619783 ↗
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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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