Events

Recall of Device Recall Dovetail Intercalary component

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
    65591
  • Event Risk Class
    Class 1
  • Event Number
    Z-1820-2013
  • Event Initiated Date
    2013-07-11
  • Event Date Posted
    2013-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119676
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The lps lower extremity dovetail intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
  • Action
    On 7/11/13, URGENT MEDICAL DEVICE RECALL NOTIFICATIONS were sent to consignees: Depuy Distributors, hospitals, and surgeons. End-user Hospital Customers will submit reconciliation forms to DePuy. Possible clinical implications of device failure are stated in these notifications, including poor mechanics and loss of function, pain, component dislocation, adverse tissue reaction, bone damage, potential need for revision surgery and the risks associated with this type of surgery. A patient letter will be included with the surgeon letter to assist in surgeon's notification and discussion with patients. The devices will be returned to DePuy Warsaw through the normal DePuy Returns process, to attention of Returns and marking H13-13 on the outside of the box. If a patient presents with a fractured LPS" Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines LPS" Lower Extremity Dovetail Intercalary component is the best treatment option, DePuy plans to make the LPS" Lower Extremity Dovetail Intercalary component available through authorized approvals. Directions on how to purchase the component are provided in the Recall Communications. Any questions or concerns about the recall, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8am-5pm EDT)

Device

Device Recall Dovetail Intercalary component
  • Model / Serial
    CATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1.  In certain documentation, these alphanumeric lot numbers may appear with three zeros at the end (e.g. A1TAR1 may appear as A1TAR1000).
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY.
  • Product Description
    LPS Lower Extremity Dovetail Intercalary component. || Intended for use in replacement of the mid-shaft portion of the femur.
  • 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