RECLAIM 34-185-0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295536093), received between Aug 2, 2024 and Apr 27, 2026 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionApr 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING INSPECTION, THE REPORTER FOUND REAMERS TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999385 ↗
• InjuryJan 3, 2025Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method; 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: Foreign Body In Patient; Insufficient Information

  MAUDE report 21067572 ↗
• MalfunctionAug 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON BENT SCREWDRIVER FAILING TO DISCONNECT PROXIMAL GUIDE POST FROM DISTAL REAMER USING RECLAIM MONOBLOC. SHORT DELAY IN SURGERY CAUSING SURGEON TO SWITCH SYSTEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19891092 ↗