RECLAIM 1975-20-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295076902), received between Sep 8, 2017 and Feb 28, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).

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.

• InjuryFeb 28, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY IN THIS CASE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18803443 ↗
• InjuryJul 27, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT HAD APPEARED THAT THE STEM HAD SUBSIDED AND WAS CAUSING CONCERN. THE SURGEON REVISED BY TAKING OUT ALL IMPLANTS AND REVISING TO A LARGER DIAMETER RECLAIM STEM, A NEW CUP WITH A CONSTRAINED LINER. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12235376 ↗
• InjuryDec 3, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT REVISED DUE TO LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. A NEW RECLAIM BODY AND HEAD WERE IMPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9403953 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS LARGE SPIRAL FRACTURE AND STEM LOOSENING AT BONE TO IMPLANT INTERFACE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6851936 ↗

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