Events

Recall of Device Recall PROFEMUR(R) R RASP HANDLE

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
    75888
  • Event Risk Class
    Class 2
  • Event Number
    Z-0943-2017
  • Event Initiated Date
    2016-11-17
  • Event Date Posted
    2017-01-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151591
  • 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/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. the broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
  • Action
    MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to PostMarket@ortho.microport.com. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.

Device

Device Recall PROFEMUR(R) R RASP HANDLE
  • Model / Serial
    Lot Number US100122
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to Spain, China, and Italy
  • Product Description
    PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN || Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.