Events

Recall of Device Recall METS SMILES Total Knee Replacement

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
    74403
  • Event Risk Class
    Class 2
  • Event Number
    Z-2553-2016
  • Event Initiated Date
    2016-05-31
  • Event Date Posted
    2016-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147402
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Reason
    The manufacturer has identified that the stated femoral plateau plates may not fit into the intended femoral knee mating component and thus sit flush upon the femoral knee component prior to implantation.
  • Action
    The recalling firm sent recall notification letters to their consignees on 05/31/2016. Follow up communciation was sent out on 7/26/2016 after a technical and medical assessment was completed.

Device

Device Recall METS SMILES Total Knee Replacement
  • Model / Serial
    Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Directly distributed to TX, further distributed to AL and MS
  • Product Description
    METS SMILES Total Knee Replacement
  • 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