Skip to content

Echo FX™ Hip System 192517Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868260926), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K070274); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Inaccurate Information1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 27, 2020Inaccurate Information; Inaccurate Information

    IT WAS REPORTED THAT THE PART NUMBER ON THE LABEL 192517 IS FOR AN ECHO BI-METRIC REDUCED PROXIMAL PROFILE 17 X 165 MM FEMORAL STEM. THE DESCRIPTION ON THE LABEL IS FOR AN ECHO FX LATERALIZED 17 MM STEM, WHICH SHOULD BE PART NUMBER 12-151417. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10460582 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070274. One submission often covers many models, so check the product and lot details in each record.

  • Z-2821-2018 · Jun 8, 2018 · Terminated
    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
  • Z-0300-2018 · Jun 5, 2017 · Terminated
    ECHO POR FMRL NC 9X125, model # 192009
  • Z-0442-2013 · Nov 6, 2012 · Terminated
    Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoar

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.