RECLAIM 44-00000-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295537229), received between Jul 14, 2023 and Jan 28, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT THE ROCKING RING BROKEN OFF NECK TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203081 ↗
• InjuryJan 3, 2025Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method

  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: Foreign Body In Patient; Insufficient Information

  MAUDE report 21067581 ↗
• MalfunctionOct 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TRIALING OF THE RECLAIM MONOBLOCK STANDARD NECK THE HEAD TRIAL WAS NOT PROPERLY CONNECTING WITH THE NECK TRIAL. ALTERNATE NECK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372484 ↗
• MalfunctionFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NECK TRIALS SNAP RING IS NO LONGER ATTACHED TO THE TRUNION. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785479 ↗
• MalfunctionJul 14, 2023Break; Break

  IT WAS REPORTED THAT THE RETAINING CLIP ON THE STD OFFSET NECK SEGMENT FOR THE RECLAIM MONOBLOC NECK SEGMENT WAS KNOCKED OFF WHILE TRYING TO EXTRACT THE DISTAL FEMORAL REAMER. ALL PIECES WERE RETRIEVED AND THE PATIENT WAS NOT HARMED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327989 ↗