Events

Recall of Stryker Custom Cranial Implant Kit

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
    50172
  • Event Risk Class
    Class 1
  • Event Number
    Z-0510-2009
  • Event Initiated Date
    2008-10-24
  • Event Date Posted
    2008-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74898
  • 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
    Lack of assurance of sterility.
  • Action
    The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.

Device

Stryker Custom Cranial Implant Kit
  • Model / Serial
    All units.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. || Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

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