Events

Recall of Device Recall MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPORTitaniumBarrier (MTB) Right

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

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
    70166
  • Event Risk Class
    Class 2
  • Event Number
    Z-1093-2015
  • Event Initiated Date
    2014-12-17
  • Event Date Posted
    2015-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132388
  • 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, polymeric - Product Code FTL
  • Reason
    Article #81036 (medpor titan max ofw - mtb - right) reportedly contained article #81035 medpor titan max ofw - mtb - left. the appropriate articles were actually included in the shipment. however, the products had an incorrect barrier location.
  • Action
    Stryker sent an Urgent Medical Device Recall Notice dated December 23, 2014, to all affected customers with a response form to be completed and returned upon receipt and review. The letter identified the affected product, potential hazards, risk mitigation and the actions to be taken. For questions contact Stryker CMF at 1-800-962-6558, or e-mail at CMF-custserv@stryker.com.

Device

Device Recall MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPORTitaniumBarrier (MTB) Right
  • Model / Serial
    Part Number 81036; Lot Number A1402020, A1405060
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
  • Product Description
    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right || Product Usage: || MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Manufacturer Address
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA