Events

Recall of Device Recall DePuy Spine EXPEDIUM Offset Torque Wrench

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
    62719
  • Event Risk Class
    Class 2
  • Event Number
    Z-0685-2013
  • Event Initiated Date
    2012-07-24
  • Event Date Posted
    2013-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111486
  • 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
    Wrench - Product Code HXC
  • Reason
    A component within the handle of the expedium offset torque wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.
  • Action
    DePuy Spine issued an Urgent - Voluntary Product Recall Notification dated July 24, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue the use of the affected product and to remove the EXPEDIUM¿ Offset Torque Wrenches from service and return to DePuy Synthes Spine until direction can be provided by DePuy Synthes Spine regarding a replacement torque limiting device. For questions regarding this recall call 508-828-3769.

Device

Device Recall DePuy Spine EXPEDIUM Offset Torque Wrench
  • Model / Serial
    All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
  • Product Description
    DePuy Spine EXPEDIUM Offset Torque Wrench || Product Code 2797-29-510 || The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
  • 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