Events

Recall of EXPEDIUM

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
    71067
  • Event Risk Class
    Class 2
  • Event Number
    Z-1674-2015
  • Event Initiated Date
    2015-04-21
  • Event Date Posted
    2015-05-26
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135980
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    Device does not mate as intended.
  • Action
    Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number.

Device

EXPEDIUM
  • Model / Serial
    LOT NUMBER: ARNDC6 & ARN DC7
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US: PA and OUS: SE, BE, IT, PT
  • Product Description
    EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Manufacturer Address
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA