Events

Recall of Device Recall METS

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
    75892
  • Event Risk Class
    Class 2
  • Event Number
    Z-0824-2017
  • Event Initiated Date
    2016-12-07
  • Event Date Posted
    2016-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151732
  • 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 recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
  • Action
    Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.

Device

Device Recall METS
  • Model / Serial
    B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • Product Description
    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • 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