Events

Recall of Device Recall JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL,

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
    54269
  • Event Risk Class
    Class 2
  • Event Number
    Z-0946-2010
  • Event Initiated Date
    2009-01-23
  • Event Date Posted
    2010-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88055
  • 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
    Knee implant - Product Code HSX
  • Reason
    The firm has received complaints of the base plates breaking in situ. if a breakage occurs, the broken baseplate must be revised and/or changed. if left unrevised a broken base could lead to instability and premature wear of the construct.
  • Action
    All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 12/23/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. For questions, please contact the firm, Leah Easley at 901-399-6137.

Device

Device Recall JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL,
  • Model / Serial
    All Lot Numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
  • Product Description
    JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933298, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
  • 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