RECLAIM 2975-00-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295155935), received between Oct 27, 2017 and Feb 17, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Mechanical Jam

  IT WAS REPORTED THAT THE RECLAIM MONO RATCHETING T-HANDLE WILL NOT RATCHET. THE WHEEL TO SWITCH RATCHET DIRECTION IS STUCK AND WILL NOT TURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368460 ↗
• InjuryJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A HIP FX CASE, THE SURGEON BEGAN USING RECLAIM MONOBLOC INSTRUMENTS PER TECHNIQUE. THE SURGEON USED THE ENTRY REAMER FOLLOWED BY THE 12MM STANDARD DISTAL REAMER, 13MM STANDARD DISTAL REAMER, AND 14MM STANDARD DISTAL REAMER. THE 14MM STANDARD DISTAL REAMER HAD GOOD CORTICAL ENGAGEMENT AND WAS USED FOR TRIALING. SURGEON PROCEEDED TO USE THE PROXIMAL REAMERS SEQUENTIALLY STARTING WITH THE 12MM STANDARD PROXIMAL REAMER, THE 13MM STANDARD PROXIMAL REAMER, AND FINALLY THE 14MM STANDARD PROXIMAL REAMER. SURGEON ATTACHED THE STANDARD TRIAL NECK AND THE TRIAL 36MM X 1.5MM HEAD. SURGEON REDUCED THE HIP AND PERFORMED RANGE OF MOTION. THE SURGEON REQUESTED IMPLANTS TO MATCH THE TRIALS. SURGEON REMOVED THE HEAD TRIAL AND THE NECK TRIAL. SURGEON BEGAN THE REMOVAL OF THE 14MM STANDARD DISTAL REAMER AND WAS NOT ABLE TO REMOVE IT. SURGEON PROCEEDED TO USE THE POWER REAMER AND WAS NOT ABLE TO REMOVE THE 14MM STANDARD DISTAL REAMER. SURGEON TRIED THE SLAP HAMMER AND WAS UNSUCCESSFUL. SURGEON THEN TRIED THE T-HANDLE FROM THE RECLAIM MONOBLOC INSTRUMENT SET UNSUCCESSFULLY. THE SURGEON DECIDED TO LEAVE THE 14MM STANDARD DISTAL REAMER IN PATIENT, REATTACH THE STANDARD NECK TRI

  Patient problems: Insufficient Information

  MAUDE report 21067569 ↗
• MalfunctionSep 24, 2024Mechanical Jam; Unintended Movement; Mechanical Jam; Unintended Movement

  RATCHET FEELS LOOSER, SURGEON FELT HANDLE WAS HARD TO TORQUE AND DID NOT WANT STEM TO GET STUCK IN THE FEMUR. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294183 ↗
• MalfunctionMay 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RATCHET T-HANDLE FOR THE CANAL REAMERS WAS NOT FUNCTIONING PROPERLY, FOLLOWING A REVISION TOTAL HIP ARTHROPLASTY. THERE ARE NO BROKEN PIECES. THERE WAS NO DELAY OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226201 ↗
• MalfunctionMar 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT RATCHET MECHANISM FOR T HANDLE WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894872 ↗
• MalfunctionJan 4, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DURING THE SURGERY, THE T-HANDLE GOT DEFECTIVE. THE CONNECTOR PIECE BETWEEN THE T-HANDLE AND REAMER IS VERY UNSTABLE AND TENDS TO BREAK. NO PATIENT CONSEQUENCE AS THE PROCEDURE COULD BE COMPLETED WITH A SAME LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097720 ↗
• MalfunctionJun 10, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  DURING INSPECTION, IT WAS NOTICED THAT PRODUCT WAS DAMAGED. ROOT CAUSE ATTRIBUTED TO THE DEVICE BEING WORN FROM NORMAL USE AND SERVICING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684129 ↗
• MalfunctionOct 27, 2017Break; Break

  IT WAS REPORTED THAT THE HANDLE WILL NOT HOLD IN A RATCHET POSITION TO ENABLE TURNING OF REAMER. AUGUST 25, 2017 - EVALUATION OF THE RETURNED INSTRUMENT FOUND THE ATTACHMENT COMPONENTS BROKE OFF THE HANDLE. TINY SCREW AND SPRING COMPONENTS WERE FOUND THAT BROKE FROM THE ATTACHMENT COMPONENT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6984675 ↗