Events

Recall of Device Recall LEGION(R) FEM CONE IMPACTOR HEADS

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
    77413
  • Event Risk Class
    Class 2
  • Event Number
    Z-2625-2017
  • Event Initiated Date
    2017-05-30
  • Event Date Posted
    2017-06-12
  • 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=155986
  • 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 incorrect loctite adhesive was used to assemble the impactor heads.
  • Action
    The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.

Device

Device Recall LEGION(R) FEM CONE IMPACTOR HEADS
  • Model / Serial
    Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution to TN
  • Product Description
    LEGION(R) TIB CONE IMPACTOR HEADS: || a) REF 71441972, ID 24MM || b) REF 71441971, ID 22MM || c) REF 71441973, ID 26MM || d) REF 71441974, ID 28MM || e) REF 71441975, ID 30MM
  • 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