Events

Recall of GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 6, RIGHT

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
    66545
  • Event Risk Class
    Class 2
  • Event Number
    Z-0131-2014
  • Event Initiated Date
    2013-10-07
  • Event Date Posted
    2013-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122572
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Swapped product. non-porous tibial base size 5 l was mis-packaged as size 6 r and vice versa.
  • Action
    Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.

Device

GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 6, RIGHT
  • Model / Serial
    Batch No. 13GM09505
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
  • Product Description
    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. || Product Usage: orthopaedic
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA