Events

Recall of Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert

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
    79875
  • Event Risk Class
    Class 2
  • Event Number
    Z-1904-2018
  • Event Initiated Date
    2018-03-30
  • 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=163793
  • 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
    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
  • Action
    The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.

Device

Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert
  • Model / Serial
    Batch Number 16EM12620
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
  • Product Description
    smith&nephew; LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA