RECLAIM 2975-00-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295155898), received between Jun 29, 2017 and Aug 27, 2026 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (20 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 51 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 50484046 ↗
• 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 24753143 ↗
• 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 24716801 ↗
• 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 24530647 ↗
• 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 24497822 ↗
• 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 24183400 ↗
• 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 23392079 ↗
• MalfunctionMay 13, 2025Calibration Problem; Mechanical Jam; Calibration Problem; Mechanical Jam

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

  Patient problems: Insufficient Information

  MAUDE report 22012122 ↗
• 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 21048059 ↗
• 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 20338655 ↗
• 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 19742849 ↗
• 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 17909574 ↗
• 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 17565787 ↗
• 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 17398363 ↗
• MalfunctionJun 29, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT HANDLE IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231514 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT THE RECLAIM TORQUE T-HANDLE WAS COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199411 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM BOLT WRENCH STRIPPED WHILE APPLYING FINAL TORQUE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153824 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ASSEMBLY LOCKING SCREW TORQUE WRENCH IS ENGAGED AND STUCK TOGETHER. THE EVENT DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788570 ↗
• MalfunctionDec 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE HAS DISCONNECTED FROM THE DRIVER. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923832 ↗
• MalfunctionAug 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE CLEANING UP IT WAS DISCOVERED THAT THE RECLAIM BOLT TORQUE WRENCH AND BOLT TORQUE WRENCH HANDLE COULD NOT BE SEPARATED AS THE CONNECTION POINT HAD BEEN DAMAGED. PRODUCTS BEING RETURNED AND DER COMPLETED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266324 ↗
• MalfunctionJun 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TORQUE WRENCH HANDLE AND BODY WILL NOT SEPARATE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694883 ↗
• MalfunctionFeb 16, 2022Break; Break

  T-HANDLE CAME APART FROM METAL QUICK CONNECT PIECE WHEN REMOVED FROM TORQUE WRENCH BODY AFTER USE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544326 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT THE TORQUE HANDLE HAS SEPARATED INTO TWO PIECES. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. CUSTOMER REFERENCE/PO/SERVICE: (B)(6), PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, 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 13542841 ↗
• MalfunctionNov 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO UNRELATED ITEMS WERE DEEMED DEFECTIVE AND UNUSABLE FOR THE RECLAIM INSTRUMENTS. FIRST, THE 40MM TRIAL NECK HEX SCREW BROKE. SECOND, THE BOLT TORQUE WRENCH BECAME COLD WELDED TO THE PRONGED STEM STABILIZER. NEED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824355 ↗
• MalfunctionNov 9, 2021Material Deformation; Material Deformation

  INTRAOPERATIVELY THE INSTRUMENT FRACTURED. SURGERY DELAY ABOUT 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12778540 ↗