RECLAIM 2975-00-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295155904), received between Sep 7, 2017 and Aug 27, 2026 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (22 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Material Deformation

  It was reported that instruments were rounded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484053 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS ARE NOT WORKING, JUST SPINNING AROUND AND NOT TORQUING THE SCREW. THERE WAS A THREE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753180 ↗
• 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 24717924 ↗
• MalfunctionMar 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE AND DRIVER ARE GETTING STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530679 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT T HANDLE ON BOLT TORQUE WRENCH NO LONGER ENGAGES OR TORQUES OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497708 ↗
• MalfunctionJan 26, 2026Material Deformation

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE RECLAIM MODULAR INSTRUMENTS WERE STRIPPED OUT AND NON-FUNCTIONAL. THE SURGEON HAD TO TRIAL OFF REAL IMPLANTS. THERE WAS NO PATIENT HARM, BUT THE PROCEDURE WAS DELAYED BY NINETY MINUTES DUE TO THE INABILITY TO PROPERLY TRIAL AND STRUGGLE WITH THE INSTRUMENTS. ACTIVITY LEVEL ¿ YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183439 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT AFTER IMPLANT, DURING THE SURGICAL PROCEDURE, IT WAS OBSERVED THAT PART THE PLASTIC ON THE INSTRUMENT WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086159 ↗
• MalfunctionJan 14, 2026Material Deformation

  IT WAS REPORTED THAT PROLONGED STEM STABILIZER FOR THE LOCKING BOLT WAS STRIPPED WHERE THE T HANDLE CONNECTS (OFFICE SET).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071751 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT THE BLACK RING BROKE OFF OF BODY AT THE NECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019768 ↗
• MalfunctionDec 11, 2025Material Deformation; Material Deformation

  RECLAIM TORQUE ASSEMBLY STRIPPED AND FAILED TO PROPERLY TORQUE FINAL BOLT IMPLANT. SURGEON MANUALLY TORQUED BOLT WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 3, ACTION TAKEN WHEN EVENT OCCURRED? --> SURGEON MANUALLY TORQUED FINAL BOLT, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, (B)(6) DEVICE PROPERTY OF -->OTHER, DEVICE IN POSSESSION OF -->HOSPITAL, (B)(6) DEVICE PROPERTY OF -->OTHER, DEVICE IN POSSESSION OF -->HOSPITAL 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 23783278 ↗
• MalfunctionDec 11, 2025Calibration Problem; Material Deformation; Calibration Problem; Material Deformation

  RECLAIM TORQUE ASSEMBLY STRIPPED AND FAILED TO PROPERLY TORQUE FINAL BOLT IMPLANT. SURGEON MANUALLY TORQUED BOLT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 3, ACTION TAKEN WHEN EVENT OCCURRED? --> SURGEON MANUALLY TORQUED FINAL BOLT, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, (B)(4). DEVICE PROPERTY OF -->OTHER, DEVICE IN POSSESSION OF -->HOSPITAL, (B)(4). DEVICE PROPERTY OF -->OTHER, DEVICE IN POSSESSION OF -->HOSPITAL 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 23783153 ↗
• MalfunctionOct 27, 2025Break; Device-Device Incompatibility; Break; 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 23391946 ↗
• MalfunctionSep 17, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE ITEM DIDN'T CONNECT TO ANY OF THE T-HANDLES AS IT SHOULD. MADE IT DIFFICULT TO GET THE LOCKING BOLT TO GO DOWN ON DEFINITIVE STEM. DID PRODUCE SOME METAL SHARDS AS WELL THAT WERE COMING OFF OF THE INSTRUMENT BUT WERE REMOVED EASILY. THERE WAS NO ADVERSE AFFECT TO PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073178 ↗
• MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE RA90430072G HAD A MISSING KNOB AND BROKEN LEVER, THE DEVICE 297500400 HAD A MISSING BACK AND TOP PIECE, THE DEVICE 254401006 WAS CRACKED AND CHIPPED, THE DEVICE 255000100 HAD A PIECE STICKING OUT AND IS COMING APART, AND THE DEVICE 257005000 HAD A CROSS THREADED TIP. IT DIDNT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532439 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN PRONGED STEM STABILIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385399 ↗
• MalfunctionMay 13, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT BOLT TORQUE WRENCH BODY AND HANDLE WILL NOT TORQUE LIMIT.

  Patient problems: Insufficient Information

  MAUDE report 22012167 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THE WRENCH AND T-HANDLE BROKE DURING A RECLAIM HIP CASE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048071 ↗
• MalfunctionSep 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A HIP SURGERY ON (B)(6) 2024 THAT THE T HANDLE WOULD NOT ATTACH BECAUSE IT WAS TOO TIGHT AND WOULD NOT FIT. THERE WAS NO SURGICAL DELAY AND NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339224 ↗
• MalfunctionJul 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOLT WRENCH HANDLE THIS USE WITH WENCH BODY. WE REALIZED THAT THE STERILE PROCESSING TECHNICIAN COULDN¿T ASSEMBLE THE HANDLE FROM THE WRENCH BODY AND UPON GETTING DOWN TO ENGAGE QUICK CONNECT IN THE MECHANISM ON BOTH WRENCH HANDLE AND WRENCH BODY IN THE STRIPS..

  Patient problems: Insufficient Information

  MAUDE report 19742823 ↗
• MalfunctionMay 3, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE WAS SEIZED UP. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238241 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY DURING THE CASE. THE TECH SIMPLY COULD NOT PULL THE HANDLES APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909568 ↗
• MalfunctionAug 17, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DEVICE IS BROKEN DUE TO WEAR AND TEAR. NO DELAY ON SURGERY NO IMPACT ON PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565775 ↗
• MalfunctionJul 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TORQUE WRENCH BODY AND T-HANDLE CONNECTION WERE STRIPPED. ASSEMBLY TOOL ADAPTERS ARE NOT BEING RETAINED ON THE HOUSING. REAMER EXTRACTOR ADAPTER IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398360 ↗
• MalfunctionJun 29, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231563 ↗
• MalfunctionJun 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM BOLT WRENCH STRIPPED WHILE APPLYING FINAL TORQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162396 ↗