RECLAIM 2975-00-500Recalls & reported problems
Depuy (Ireland) · RECLAIM DISTAL REAMER EXTENSION · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Reclaim distal reamer extension is a surgical tool used to prepare the bone at the end of an implant. The 27 reports mostly describe handles and parts breaking, twisting or coming loose, so the handle would not lock onto the reamer or would not spin; missing springs, sleeves and coils were also noted. No deaths and no injuries were reported, and 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295155911), received between Apr 12, 2018 and Mar 24, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Device-Device Incompatibility9
- Detachment of Device or Device Component5
- Material Twisted/Bent3
- Naturally Worn2
- Component Missing1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient9
- Insufficient Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AT THE START OF THE CASE, IT WAS NOTICED THAT THE COIL WHICH HOLDS THE WHITE SLEEVE HANDLE ONTO THE REAMER WAS MISSING. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21679646 ↗MalfunctionSep 5, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
DURING INSPECTION IT WAS DETERMINED REAMER HANDLES DO NOT ATTACH TO THE REAMERS PROPERLY. ASSEMBLY TOOL IS NOT PROPERLY THREADING INTO THE DISTAL STEM OF THE IMPLANT PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148299 ↗MalfunctionSep 5, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
DURING INSPECTION IT WAS DETERMINED REAMER HANDLES DO NOT ATTACH TO THE REAMERS PROPERLY. ASSEMBLY TOOL IS NOT PROPERLY THREADING INTO THE DISTAL STEM OF THE IMPLANT PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148279 ↗MalfunctionJul 17, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HUDSON ADAPTER WILL NO LONGER ENGAGE THE HUDSON.
Patient problems: Insufficient Information
MAUDE report 19759727 ↗MalfunctionApr 30, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT REAMER EXTENSION WOULDN'T LOCK ON THE REAMER. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19212103 ↗MalfunctionJan 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHITE SLEEVE IS MISSING SPRING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18565333 ↗MalfunctionJan 11, 2024Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT THE SPRING ON THE WHITE PART OF THE REAMER HANDLE BROKE OFF, LOCKING THE HANDLE AND NOT ALLOWING IT TO SPIN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18496704 ↗MalfunctionOct 17, 2023Break; Break
IT WAS REPORTED THAT THE RECLAIM DIST REAMER EXTENSION HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17953686 ↗MalfunctionSep 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THIS INSTRUMENT IS COMPOSED OF THE 3 PARTS. THE SPRING IS MISSING FROM THE REAMER EXTENSION HANDLE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17817675 ↗MalfunctionSep 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCRUB NOTICED DURING SET UP FOR CASE THAT THE REAMER BROACH EXTENSION WOULD NOT SEAT PROPERLY TO THE DRILL. NO ISSUE TO CASE OR SURGERY. THEY HAD A SECOND ONE IN THE TRAY SO CASE CONTINUED AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17733756 ↗MalfunctionSep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WHITE SLEEVE ON THE REAMER HANDLE WAS SLIDING OFF THE SHAFT AND THE INNER SPRING IN THE WHITE SLEEVE WAS MISSING. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? - NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? - NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS?- NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES - NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: - NO, IS THE PATIENT PART OF A CLINICAL STUDY - UNKNOWN, IP-01828100 DEVICE PROPERTY OF - OTHER, DEVICE IN POSSESSION OF - 1. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.- TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690984 ↗MalfunctionJan 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WHITE TUBE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16097141 ↗MalfunctionJan 11, 2022Device-Device Incompatibility; Device-Device Incompatibility
HANDLE ISN'T LOCKING ONTO THE REAMER ANYMORE. WRENCH IS STRIPPED WHERE IT ATTACHES TO THE ASSEMBLY TOOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13227709 ↗MalfunctionAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO PIECES BROKEN OFF FROM THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12331603 ↗MalfunctionJul 29, 2021Break; Break
IT WAS REPORTED THAT THE SPRING CAME OUT OF THE HANDLE. NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12247756 ↗MalfunctionJan 8, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SEVERAL RECLAIM INSTRUMENTS WITH THREADS WERE DAMAGED DURING NORMAL USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11141562 ↗MalfunctionJan 8, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SEVERAL RECLAIM INSTRUMENTS WITH THREADS WERE DAMAGED DURING NORMAL USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11141550 ↗MalfunctionJul 8, 2020Break; Break
IT WAS REPORTED THAT THE WHITE HANDLE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10245382 ↗MalfunctionJan 14, 2020Break; Break
IT WAS REPORTED THAT THE SPRING BROKE IN WHITE HANDLE. ALL PIECES RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9587210 ↗MalfunctionJan 7, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SPRING WILL NOT HOLD THE WHITE POLY HANDLE IN PLACE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9557496 ↗MalfunctionMay 17, 2019Component Missing; Component Missing
IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS PRIOR TO STERILIZATION. HE REALIZED THAT THE HANDLE ON THE DISTAL REAMER EXTENSION WAS MISSING A SPRING. THIS WAS NOT USED IN SURGERY AND SURGERY WAS NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8621611 ↗MalfunctionMay 6, 2019Break; Break
DISTAL REAMER BROKE AFTER USE OF SURGERY. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583977 ↗MalfunctionFeb 6, 2019Break; Break
REAMER HANDLE BROKEN. NEEDS REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8311238 ↗MalfunctionJan 4, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RECLAIM DISTAL REAMER EXTENSION WILL NOT ATTACH TO THE DRILL CHUCK. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8217737 ↗MalfunctionNov 15, 2018Material Twisted/Bent; Material Twisted/Bent
INSTRUMENT COMPLAINT DURING THR REVISION REAMER HANDLE EXTENSION HAS DAMAGED SPRING HOLDING WHITE HANDLE ON TO THE REAMER. STEM INTRODUCER HAS RUBBER COMING OFF HANDLE. ACTION TAKEN TO MANAGE THE PROBLEM DURING THE PROCEDURE: STILL USED HANDLE, THE WHITE PIECE JUST MOVES AROUND. NO AE TO PATIENT. NO DELAY TO THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8075399 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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.
How reports and recalls are matched · Editorial policy · Report an error on this page