RECLAIM 1975-28-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295076964), received between Oct 19, 2018 and Aug 20, 2019 — classified as 3 injuries.

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

• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS INFECTION. UPDATE 12/8/2014- PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS PROVIDED. THIS COMPLAINT IS NOW LEGAL. THERE ARE NO SPECIFIC ALLEGATIONS FOR THIS REVISION. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED INFLAMMATION, SUBLUXATION, AND NO INFECTION AS PREVIOUSLY STATED. ONLY THE LINER WAS CHANGED TO A COMPETITOR CONSTRAINED LINER. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 1/6/2015. UPDATE AD 30 JUL 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO PPF AND IMPLANT RECORD. PPF ALLEGES FRACTURE, DISLOCATION WITH OPEN REDUCTION AND ELEVATED METAL IONS. DOI: (B)(6) 2013 - DOR: (B)(6) 2014, (LEFT HIP).

  Patient problems: Inflammation; No Code Available; Test Result

  MAUDE report 8910426 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND SURGEON REMOVED ALL COMPONENTS. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8683920 ↗
• InjuryOct 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE RECLAIM STEM AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7984968 ↗

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-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
• 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