Events

Recall of SIW Patient Specific Distal Femur device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanmore Implants Worldwide Ltd..

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
    73856
  • Event Risk Class
    Class 2
  • Event Number
    Z-1623-2016
  • Event Initiated Date
    2016-04-12
  • Event Date Posted
    2016-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145198
  • 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
    Distal Femoral Replacement - Product Code JWH
  • Reason
    Incorrect component used to manufacture distal femoral replacement.
  • Action
    A notification was sent to the prescribing physician on 04/12/2016.

Device

SIW Patient Specific Distal Femur device
  • Model / Serial
    Device Identifier: PIN 19960, Lot: 19960
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution to OH.
  • Product Description
    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
  • Manufacturer
    Stanmore Implants Worldwide Ltd.

Manufacturer

Stanmore Implants Worldwide Ltd.
  • Manufacturer Address
    Stanmore Implants Worldwide Ltd., 210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood United Kingdom
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA