Events

Recall of Device Recall DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Spine, Inc..

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
    51138
  • Event Risk Class
    Class 2
  • Event Number
    Z-1670-2009
  • Event Initiated Date
    2009-02-11
  • Event Date Posted
    2009-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78807
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Reason
    Tip of driver may break during use.
  • Action
    DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.

Device

Device Recall DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft,
  • Model / Serial
    Product Code: 2894-10-300; Lot Number: 1208NT.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
  • Product Description
    DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Manufacturer Address
    DePuy Spine, Inc., 325 Paramount Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA