Recall of Device Recall GENESIS II/LEGION Resurfacing Patella with JOURNEY Peg

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
    72866
  • Event Risk Class
    Class 2
  • Event Number
    Z-0573-2016
  • Event Initiated Date
    2015-11-09
  • Event Date Posted
    2016-01-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-03-17
  • Event Source
    USFDA
  • Event Source URL
  • 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
    One lot of 35 mm patella implants is labeled as 32 mm. these implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
  • Action
    The firm, Smith & Nephew Inc, notified the distributors by Fed- Ex on 10/20/2015 and sent an "Urgent - Product Recall 1st Notification - Urgent R-2015-22" letter dated 11/9/2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices, quarantine them immediately, complete and return the Inventory Return Certification Form by fax to: +1-901-566-7975 or email to: FieldActions@smith-nephew.com, even if you do not have the product, contact Smith & Nephew's Field Actions Department via email or fax (above) to obtain a return authorization (RA) number, and return any affected product to Smith & Nephew, Attn: Global Field Actions, Global Distribution Center, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, call Director, Regulatory Affairs 901-399-5520 or email: jason.sells@smith-nephew.com.

Device

  • Model / Serial
    Batch # 15GM07831
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of:FL, MO, IN and TX.
  • Product Description
    Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 || knee implant.
  • Manufacturer

Manufacturer

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