Events

Recall of GENESIS II TIBIAL DRILL GUIDE

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
    55673
  • Event Risk Class
    Class 2
  • Event Number
    Z-1900-2010
  • Event Initiated Date
    2010-04-20
  • Event Date Posted
    2010-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91516
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side.
  • Action
    All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.

Device

GENESIS II TIBIAL DRILL GUIDE
  • Model / Serial
    Batch # 08JM07761 and 08JM07761A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.
  • Product Description
    GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA || Drill guide used as manual surgical instrument during knee replacement surgeries.
  • 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