RECLAIM 1975-20-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295076896), received between Mar 25, 2021 and Oct 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K102080); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23378112 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING AND WAS REVISED DUE TO VERSION ANGLE. IT HAD BEEN PUT AT THE WRONG VERSION ANGLE AND NEEDED TO BE ADJUSTED. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY OR CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIZE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21929193 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE WAS A SECOND STAGE REVISION, PATIENT HAD PREVIOUS IMPLANT REMOVED APPROX 8 WEEKS AGO, NON JNJ IMPLANTS, DUE TO INFECTION. CEMENT SPACER WAS REMOVED AND THE FEMUR AND ACETABULUM WERE LAVAGED EXTENSIVELY. THE PATIENT WOUND WAS THEN CLOSED AND REDRAPED WITH NEW DRAPES AND NEW SET OF STERILE INSTRUMENTS. ACETABULUM WAS PREPPED FOR PINNACLE MULTI HOLE CUP AND WAS IMPLANTED WITH 2 SCREWS AND DUAL MOBILITY LINER, WITH NO ISSUES. FEMUR WAS THEN PREPARED FOR RECLAIM STEM, REAMED TO 20MM AND 20X190 ANGLED STEM WAS IMPLANTED. TRIAL PERFORMED USING 95X40 TRIAL NECK. DEFINITIVE PROXIMAL BODY WAS PLACED IN THE USUAL FASHION FOLLOWING THE SURGICAL TECHNIQUE, THE TAMP WAS USED TO ENGAGE THE BODY TO THE TAPER ON THE STEM, THE ASSEMBLY TOOL WAS THEN USED TO SEAT THE TAPER. THE SURGEON NOTED A SOUND JUST PRIOR TO THE TENSILE BAR BROKE. WHEN HE REMOVED THE ASSEMBLY TOOL HE NOTED THAT THE BODY APPEARED LOOSE. THE SUSPICION WAS THAT THE FEMUR HAD FRACTURED, WE REMOVED ALL THE IMPLANTS AND TOOK AN X-RAY WHICH CONFIRMED THE FRACTURE WHICH HAS APPEARED TO BEGIN AT THE WEAK POINT WHERE THE SINUS IN THE PROXIMAL FEMUR HAD BEEN DUE TO THE INFECTION. THE FRACTURE WAS REDUCED USING CABLES AND A DISTAL

  Patient problems: Limb Fracture

  MAUDE report 19106113 ↗
• InjuryMar 25, 2021Migration; Migration

  IT WAS REPORTED THAT THE STEM SUBSIDED AND REQUIRED REVISION. DOI: (B)(6) 2019 DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11568256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102080. One submission often covers many models, so check the product and lot details in each record.

• Z-2084-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf
• Z-2082-2014 · Jun 3, 2014 · Terminated
  RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during
• Z-2083-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking ta