Events

Recall of Device Recall DePuy Offset Wire Fixation Bolt used in AceFischer External Fixation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, 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
    60325
  • Event Risk Class
    Class 2
  • Event Number
    Z-0508-2012
  • Event Initiated Date
    2011-11-08
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105036
  • 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
    Holder, needle; Orthopedic - Product Code HXK
  • Reason
    Depuy has received three complaints concerning oversized bolt threads in the offset wire fixation bolts used in the ace- fischer external fixation system. this could lead to the inability to properly thread the nut onto the bolt.
  • Action
    On 11/9/2011 DePuy sent "Medical Device Recall Notice" letters to Distributors and to direct account hospitals. Recall notices included instructions to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN via distributors and sales representatives. The product is going to be discontinued and no reconditioning or reworking for the product is planned. For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - pm EST.)

Device

Device Recall DePuy Offset Wire Fixation Bolt used in AceFischer External Fixation System
  • Model / Serial
    Catalog: 8180-50-006, Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA