Events

Recall of Device Recall PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MicroPort Orthopedics Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74752
  • Event Risk Class
    Class 2
  • Event Number
    Z-2588-2016
  • Event Initiated Date
    2016-06-30
  • Event Date Posted
    2016-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148384
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Product Code LWJ
  • Reason
    Profemur(r) neck, item number pha01222 (short ar vv2 ti neck) was labeled as item number pha01212 (short ar vv1 ti neck).
  • Action
    The firm initiated their recall by email on 06/30/2016.

Device

Device Recall PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK
  • Model / Serial
    Lot number 1645222
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Italy, Spain, and Poland
  • Product Description
    PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.