RECLAIM 2975-00-635Recalls & reported problems
Depuy (Ireland) · RECLAIM ASSEMBLY UPPER PULL ROD · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Reclaim pull rod is part of a surgical extractor tool. Many reports describe parts bending, breaking, or jamming, and threads stripping. The 156 reports include no deaths and 2 injuries. 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
- 157
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10603295156017), received between Jul 26, 2017 and Aug 11, 2026 — classified as 2 injuries, 155 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility47
- Naturally Worn31
- Break30
- Material Deformation21
- Mechanical Jam20
- Material Twisted/Bent18
- Appropriate Device Problem Term/Code Not Available8
- Crack4
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- No Consequences Or Impact To Patient38
- Insufficient Information14
- No Information10
- Not Applicable10
- No Code Available8
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214351 ↗MalfunctionJun 16, 2026Material Deformation
IT WAS REPORTED THAT THREADS ARE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25519839 ↗MalfunctionApr 15, 2026Break
ASSEMBLY TOOL ON RECLAIM TENSIONER WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887772 ↗MalfunctionApr 1, 2026Material Integrity Problem
IT WAS REPORTED THAT THE PART ARRIVED DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756490 ↗MalfunctionMar 30, 2026Mechanical Jam
IT WAS REPORTED THAT THE FITTINGS OF THE PIECES WERE STUCK AFTER USE OF THE RECLAIM DEVICES AND COULD NOT BE UNCLIPPED. THE EVENT OCCURRED POST-SURGERY. THERE WERE NO COMPLICATIONS OR PATIENT HARM. THERE WAS NO SIGNIFICANT DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717465 ↗MalfunctionMar 13, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ROD WAS BENT AND IT WON¿T CAPTURE THE EYE GLASS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590967 ↗MalfunctionMar 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE INSERTER FOR RECLAIM IS STICKING TOGETHER, AND UNABLE TO PROPERLY PUT TOGETHER OR TAKE APART. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557771 ↗MalfunctionJan 14, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW TOP OF THE ASSEMBLY TOOL BECAME COLD-WELDED AND WOULD NO LONGER TURN AS IT IS SUPPOSED TO. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AND SURGICAL TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075819 ↗MalfunctionDec 9, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE RECLAIM ASSEMBLY PULL ROD THREAD WAS NOT WORKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756096 ↗MalfunctionNov 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THREADS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476000 ↗MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT NOTHING BROKE SPECIFICALLY, JUST STUCK TOGETHER. INSTRUMENTS CANNOT BE USED IF NOT TAKEN A PART SO THEY WERE TAKEN OUT OF THE ROTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391636 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT THE RECLAIM ASSEMBLY TOOL BROKEN IN HALF. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23370586 ↗MalfunctionOct 22, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT WHILE TAKING APART THE RECLAIM ASSEMBLY TOOL PULL ROD AFTER THE CASE FOR CLEANING THE THREADS WERE STUCK AND WAS UNABLE TO SCREW BACK TO ORIGINAL STARTING POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357748 ↗MalfunctionOct 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE THREADS ON THE TENSIONING DEVICE WERE UNUSABLE. TEAM WAS ONLY ABLE TO IMPACT THE PROXIMAL BODY ONTO THE STEM BEFORE PUTTING THE LOCKING BOLT IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323782 ↗MalfunctionSep 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY. THE ASSEMBLY TOOL AND ASSEMBLY PULL ROD KEPT COMING APART WHEN TRYING TO BE USED DURING SURGERY, AND THEN WOULDN'T COME APART AFTER THE CASE; BELIEVED TO BE CROSS THREADED. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004329 ↗MalfunctionAug 25, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN RECLAIM ASSEMBLY TOOL. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882816 ↗MalfunctionJul 22, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE STAR DRIVER TIP IS STRIPPED. THE RELCAIM PIECE'S NUT IS STUCK AND WON'T RELEASE. THE ARTICULATING SURFACE HAS A BROKEN SPRING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566382 ↗MalfunctionMay 22, 2025Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT THE ASSEMBLY PULL ROD WAS BENT, THREADED CAP JAMMED IN THE TOP POSITION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22072199 ↗MalfunctionMay 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS STRIPPED DURING SURGERY AND WILL NOT COME APART AT THE TOP. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988463 ↗MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RECLAIM DISASSEMBLY INSTRUMENT COULD NOT BE DISCONNECTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21871764 ↗MalfunctionMar 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREADS ON THE PRODUCT STRIPPED DURING THE CASE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21711016 ↗MalfunctionMar 6, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE DEVICE WAS JAMMED UP. IT WOULDN¿T FULLY SCREW IN TO ASSEMBLE FINAL PROXIMAL BODY.
Patient problems: Insufficient Information
MAUDE report 21537824 ↗MalfunctionJan 22, 2025Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21208447 ↗MalfunctionJan 17, 2025Mechanical Jam; Mechanical Jam
THE PIECE OF INSTRUMENTATION ON WHICH THE HOURGLASS IS MOUNTED FOR THE COUPLING TORQUE OF THE STEM WITH THE PROXIMAL BODY DOES NOT WORK, THE THREADED CAP IS COMPLETELY STUCK AND CANNOT BE UNSCREWED, THE TORQUE CANNOT BE APPLIED AS IT SHOULD BE.
Patient problems: Insufficient Information
MAUDE report 21180771 ↗MalfunctionNov 14, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ASSEMBLY TOOL UPPER PULL ROD HAD DAMAGED THREADS AND WOULD NOT THREAD INTO DISTAL STEM DURING IMPLANT ASSEMBLY. TAPER WAS IMPACTED AND LOCKING BOLT ADDED. THERE WAS NO DELAY IN PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20689356 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 reports
- LPS 2987-72-030Depuy (Ireland) · EXTRACTOR68 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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