Events

Recall of Genesis II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew 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
    35492
  • Event Risk Class
    Class 3
  • Event Number
    Z-1158-06
  • Event Initiated Date
    2006-04-12
  • Event Date Posted
    2006-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46262
  • 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, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer - Product Code HSX
  • Reason
    Mispackaging-a size 5 femoral component, right, box had a size 5 left component in the box.
  • Action
    All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006.

Device

Genesis II
  • Model / Serial
    05KM06224
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide-including states of LA, NC, IN, and countries of France, and Turkey
  • Product Description
    Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E Brooks Rd, Memphis TN 38116-1804
  • Source
    USFDA