Events

Recall of Device Recall Stryker CMF Customized Implant Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    67384
  • Event Risk Class
    Class 2
  • Event Number
    Z-0975-2014
  • Event Initiated Date
    2013-12-06
  • Event Date Posted
    2014-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125375
  • 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
    Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
  • Reason
    Stryker received a report from the field that an incorrect patient-specific simplex p cmf customized implant kit was delivered to a hospital.
  • Action
    Stryker Orthopaedics sent Urgent Medical Device Recall Notification letters/Product Recall Acknowledgement Forms dated 12/6/2013 to US branch/agency. surgeons, hospital risk managers, and sales representatives.

Device

Device Recall Stryker CMF Customized Implant Kit
  • Model / Serial
    510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in PA.
  • Product Description
    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) || 5444-01-102 Host Bone; Howmedica Osteonics Corp. || 325 Corporate Drive, Mahwah, NJ 07430 USA. || Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA