RECLAIM 2975-00-615Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295155973), received between Oct 18, 2017 and Jan 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• 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 24183494 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE ASSEMBLY TOOL ADAPTERS DID NOT CONNECT TO THE RECLAIM ASSEMBLY BODY. THE SURGICAL DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873000 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT THE ADAPTERS ARE MISSING INTERNAL RETAINING PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905424 ↗
• MalfunctionJan 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT IT WAS NOTICED THAT THE SPRING IS TWISTED ON 95 ASSEMBLY TOOL ADAPTOR DURING TRAY SETUP. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148919 ↗
• MalfunctionJul 30, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE HANDLE AND PRONG ON THE BODY ARE NOT LOCKING TOGETHER CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252935 ↗
• MalfunctionMar 29, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE ITEM WAS DAMAGED UPON ASSEMBLY PRIOR TO CASE INTERNAL SPRING DAMAGED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464242 ↗
• MalfunctionMay 17, 2018Component Missing; Component Missing

  RECLAIM INSTRUMENT IS MISSING A SPRING AND REQUIRES REPLACEMENT. ALSO, CORAIL ADAPTOR EXTRACTOR PIECE IS DAMAGED AND REQUIRES REPLACEMENT. (B)(4). PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7521980 ↗
• MalfunctionOct 18, 2017Break; Break

  IT WAS REPORTED THAT THE COIL SPRINGS ARE MISSING FROM THE INSIDE OF BOTH THE ASSEMBLY TOOL ADAPTORS. INSTRUMENTS WERE NOT USED IN SURGERY.

  Patient problems: No Information

  MAUDE report 6958193 ↗