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RECLAIM 1975-28-095Recalls & reported problems

Depuy (Ireland) · RECLAIM REVISION HIP SYSTEM CONICAL PROXIMAL BODY CEMENTLESS TENSILE BAR 28mm x 95mm 95mm LOCKING BOLT · Class 2 · Implant

All models of RECLAIM (149)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295076971), received between Oct 8, 2019 and Jan 6, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Osseointegration Problem1

Patient problems

  • Inadequate Osseointegration1
  • No Code Available1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 6, 2021Osseointegration Problem; Osseointegration Problem

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT HIP.

    Patient problems: Inadequate Osseointegration

    MAUDE report 11125593 ↗
  • InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE BODY AND HEAD WERE REVISED FOR INSTABILITY. DOI: (B)(6) 2018; DOR; (B)(6) 2019; LEFT HIP.

    Patient problems: No Code Available

    MAUDE report 9168680 ↗

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-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-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-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

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page