Events

Recall of Distal Femoral Jig

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
    69271
  • Event Risk Class
    Class 2
  • Event Number
    Z-0199-2015
  • Event Initiated Date
    2014-10-15
  • Event Date Posted
    2014-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130144
  • 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
    Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
  • Action
    DePuy sent an "URGENT DEVICE CORRECTION" notifications dated October 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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. For questions, please call 574-371-4917.

Device

Distal Femoral Jig
  • Model / Serial
    Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction.   Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844  ABC22845 C22845  ABC34279 C34279  ABC34280 C34280  ABC4107 C4107  ABC4108 C4108  ABC4112 C4112  ABC4113 C4113  ABC50741 C50471 254400521 ABB13662 B13662  ABB19116 B19116  ABB19117 B19117  ABB19118 B19118  ABB35392 B35392  ABB35393 B35393  ABB39835 B39835  ABB41384 B41384  ABB46872 B46872  ABB49200 B49200  ABB50724 B50724  ABB55749 B55749  ABB63598 B63598  ABB66346 B66346  ABB72107 B72107  ABB77183 B77183  ABB79390 B79390  ABB79391 B79391  ABB80712 N80712  ABC17165 C17165  ABC5023 C5023
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.
  • Product Description
    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a 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