Events

Recall of Stryker Leibinger New Generation/Universal Mandibular System

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

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
    50180
  • Event Risk Class
    Class 2
  • Event Number
    Z-0610-2009
  • Event Initiated Date
    2008-09-19
  • Event Date Posted
    2008-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74909
  • 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
    Mandibular Reconstruction Plate - Product Code JEY
  • Reason
    A template is supposed to accompany the product, but it was not included with this lot.
  • Action
    Consignees were notified via an Urgent Medical Device Recall letter dated September 2008 and requested to examine their inventory for the affected lot and return the recalled product. Customers are to fill out the attached forms to confirm the return-shipment and send it back. The firm will inform customers immediately regarding replacement deliveries.

Device

Stryker Leibinger New Generation/Universal Mandibular System
  • Model / Serial
    Lot J8100F1669.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911. || A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.
  • Manufacturer
    Stryker Leibinger USA

Manufacturer

Stryker Leibinger USA
  • Manufacturer Address
    Stryker Leibinger USA, 750 Trade Center Way Ste 200, Portage MI 49002-0482
  • Source
    USFDA