Events

Recall of Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor

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
    70043
  • Event Risk Class
    Class 2
  • Event Number
    Z-0903-2015
  • Event Initiated Date
    2014-11-10
  • Event Date Posted
    2015-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132180
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Attune intuition impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
  • Action
    DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT). For questions regarding this recall cal 574-371-4917.

Device

Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor
  • Model / Serial
    CATALOG NO. : ATTUNE INTUITION Impactors  Fixed Tibial Bearing, (254401003)  Barcode GTIN Number:  Fixed Tibial Bearing, ......... 10603295130192   ALL LOTS
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
  • Product Description
    Fixed Tibial bearing ATTUNE INTUITION Impactor || The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
  • 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