Events

Recall of Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS

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
    73609
  • Event Risk Class
    Class 2
  • Event Number
    Z-1549-2016
  • Event Initiated Date
    2016-03-11
  • Event Date Posted
    2016-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144587
  • 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 devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base plate during surgery.
  • Action
    The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock. If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com

Device

Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
  • Model / Serial
    Batch numbers: B1514883, B1509344, B1504926, B1502141.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution only in countries of: Germany and Switzerland.
  • Product Description
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N; 7500281, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
  • 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