Events

Recall of Device Recall MEDPOR TITAN

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

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
    60964
  • Event Risk Class
    Class 2
  • Event Number
    Z-0922-2012
  • Event Initiated Date
    2011-12-16
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106899
  • 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
    Mesh, surgical - Product Code FTM
  • Reason
    The template that is packaged with this implant was not packaged according to specification. the template was packaged in a single pouch instead of a double pouch.
  • Action
    "Urgent Product Recall" Notification letters and Product Accountability Forms have been sent on January 13, 2012 domestically via FedEx and Internationally via DHL. Customers were informed of the product problem and provided risk mitigation information. Return of the Product Accountability/Acknowledgement form was requested. Questions were directed to 770-254-4423.

Device

Device Recall MEDPOR TITAN
  • Model / Serial
    Catalog number: 81038, Lot Code: F001357
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
  • Product Description
    MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
  • Manufacturer
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial

Manufacturer

Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
  • Manufacturer Address
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial, 15 Dart Rd, Newnan GA 30265-1017
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA