RECLAIM 2975-00-715Recalls & reported problems
Depuy (Ireland) · RECLAIM DISASSEMBLY BODY COLLET · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Reclaim disassembly body collet is a surgical instrument used to take apart the Reclaim hip stem when a hip replacement has to be removed. The 60 reports mostly describe metal parts breaking, bending or jamming so the instrument would not come apart, sometimes forcing the surgeon to give up on it. One injury was reported and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 62
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295156086), received between Sep 8, 2017 and Sep 22, 2026 — classified as 1 injury, 61 malfunctions.
The most frequently reported specific device problem is “Break” (47 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
- Break47
- Device-Device Incompatibility15
- Material Twisted/Bent5
- Mechanical Jam2
- No Apparent Adverse Event2
- Appropriate Device Problem Term/Code Not Available1
- Disassembly1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient13
- Insufficient Information10
- No Information3
- No Code Available2
- Not Applicable2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856910 ↗MalfunctionSep 22, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856909 ↗MalfunctionMay 19, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY BODY DEVICE AND THE DISASSEMBLY BODY COLLET DEVICE WERE FOUND STUCK TOGETHER AND WOULD NOT SEPARATE. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT OR USER HARM AND NO DELAYS IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222659 ↗MalfunctionMay 12, 2026Device-Device Incompatibility
IT WAS REPORTED THAT INSTRUMENTS BROKE DURING EXPLANT. THE PROXIMAL BODY OF RECLAIM WAS COLD WELDED ONTO THE DISTAL STEM. THE DISTAL STEM DID NOT COME OUT. PATIENT WAS NOT HARMED. NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148566 ↗MalfunctionFeb 9, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE RECLAIM DISMBLY BODY COLLET DEVICE BROKE AND THE SURGEON WAS UNABLE TO USE IT. NO PATIENT CONSEQUENCES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292839 ↗MalfunctionAug 15, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP THAT IS INFECTED. IT IS UNKNOWN WHEN THE HIP WAS DONE. THE SURGEON REMOVED ALL COMPONENTS. THE RECLAIM DISASSEMBLY TOOL WAS NOT ABLE TO SEPARATE THE PROXIMAL BODY FROM THE DISTAL STEM. THE ROD THAT SEPARATES THE TAPER BENT, AND THE DEVICE THAT ATTACHES TO THE SHOULDER OF THE PROXIMAL BODY BROKE AT THE ATTACHMENT POINT. THE SURGEON PUT EXTREME PRESSURE ON THE TOOL AND IT STILL WOULD NOT SEPARATE THE BODY FROM THE STEM. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22821691 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING EXTRACTION, NO PARTS LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464401 ↗MalfunctionJun 16, 2025Break; Break
DISASSEMBLY INSTRUMENTS BROKE WHEN ATTEMPTING TO BREAK THE TAPER OF THE REMOVED RECLAIM STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212811 ↗MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO DISSASSEMBLE THE PROXIMAL BODY FROM THE DISTAL STEM. THE LOCKING PIECE OF THE BODY COULD NOT ENGAGE AND EXPAND THE COLLET WHILE IT WAS IN THE PROXIMAL BODY. THIS PREVENTED THE COLLET FROM LOCKING INTO THE PROXIMAL BODY.
Patient problems: Insufficient Information
MAUDE report 21414904 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT 85 MM 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 21056491 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY BODY COLLET BROKE WHEN REMOVING WELL FIXED RECLAIM COMPONENTS FROM PATIENT DURING REVISION SURGERY FOR INFECTION. SEVERAL METAL SHARDS LOCATED AT THE END OF THE COLLET BROKE OFF AND ALL PIECES WERE RECOVERED. PATIENT WAS NOT NEGATIVELY AFFECTED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047707 ↗MalfunctionNov 25, 2024Break; Break
PATIENT LEFT HIP WAS REVISED ON (B)(6) 2024 DUE TO INFECTION. THE INSTRUMENT BROKE WHILE SURGEON WAS REMOVING PROXIMAL BODY OFF OF IMPLANT. RECLAIM STEM AND PROXIMAL BODY EXPLANTED BECAUSE OF INFECTION. DATE OF IMPLANT UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770803 ↗MalfunctionNov 4, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING REMOVAL OF PROXIMAL BODY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20600255 ↗MalfunctionOct 30, 2024Break; Break
IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY TOOL BROKE WHILE TRYING TO DISASSOCIATE THE PROXIMAL BODY FROM THE DISTAL STEM DURING A WASHOUT FOR INFECTION.
Patient problems: Insufficient Information
MAUDE report 20566073 ↗MalfunctionOct 18, 2024Break; Break
IT WAS REPORTED THAT COLLET AND 105 TORQ SHAFT BROKE UPON PROXIMAL BODY EXTRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480438 ↗MalfunctionAug 21, 2024Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT DURING REVISION THE MODULAR RECLAIM TO BE DISASSEMBLED, FOLLOWED THE SURGICAL TECHNIQUE IN ORDER TO DISASSOCIATE THE PROXIMAL BODY FROM THE DISTAL STEM, THE DISASSEMBLY CLAMP TABS WERE DESTROYED TRYING TO TURN DOWN THE PROPERLY ASSEMBLED DISASSEMBLY TOOL. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20018447 ↗MalfunctionJun 27, 2024Break; Break
IT WAS REPORTED THAT THE SPLINES ON THE RECLAIM DISASSEMBLY TOOL SHEARED OFF.
Patient problems: Insufficient Information
MAUDE report 19623260 ↗MalfunctionJun 24, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
THE PROXIMAL BODY FOR THE RECLAIM STEM WAS ATTEMPTED TO BE REMOVED. THE DISASSEMBLY TOOL WAS INSERTED INTO PROXIMAL BODY TO DISENGAGE IT, BUT THE TEETH ON THE COLLET PORTION SHEARED OFF WHILE TRYING TO SEPARATE BODY FROM STEM. THIS WAS ATTEMPTED WITH TWO DIFFERENT DISASSEMBLY TOOLS, AND THE TEETH SHEARED OFF BOTH COLLET PORTIONS OF THE DISASSEMBLY TOOLS. THE BODY WAS NOT ABLE TO BE DISENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593149 ↗MalfunctionJun 24, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
THE PROXIMAL BODY FOR THE RECLAIM STEM WAS ATTEMPTED TO BE REMOVED. THE DISASSEMBLY TOOL WAS INSERTED INTO PROXIMAL BODY TO DISENGAGE IT, BUT THE TEETH ON THE COLLET PORTION SHEARED OFF, WHILE TRYING TO SEPARATE BODY FROM STEM. THIS WAS ATTEMPTED WITH TWO DIFFERENT DISASSEMBLY TOOLS. AND THE TEETH SHEARED OFF BOTH COLLET PORTIONS OF THE DISASSEMBLY TOOLS. THE BODY WAS NOT ABLE TO BE DISENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593143 ↗MalfunctionMar 25, 2024Break; Break
IT WAS REPORTED THAT UPON EXTRACTION TWO COLLET DISASSEMBLY TOOLS BROKE WHILE TRYING TO SEPARATE THE PROX BODY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970393 ↗MalfunctionMar 25, 2024Break; Break
IT WAS REPORTED THAT UPON EXTRACTION TWO COLLECT DISASSEMBLY TOOLS BROKE WHILE TRYING TO SEPARATE THE PROX BODY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970359 ↗MalfunctionFeb 29, 2024Break; Break
TOOL BROKE WHILE IN USE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18807872 ↗MalfunctionJan 9, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT TIP BROKE DURING EXTRACTION. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475136 ↗MalfunctionOct 25, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023, WHILE ATTEMPTING TO DISASSEMBLE A RECLAIM THE INNER ROD SNAPPED INTO THE BLUE 75 THREADED PIECE AND THE LOCKING FLOWER MECHANISM AT THE END CONTORTED. GOT STUCK IN THE PROXIMAL BODY WITHOUT BREAKING THE TAPER. WE GOT THE DISASSEMBLY DEVICE OUT WITH THESE 3 PIECES BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18001973 ↗MalfunctionSep 5, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED: A. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY. IF YES, WAS THERE ANY SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17685682 ↗
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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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