Events

Recall of Foundation Hip System Bipolar Modular

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    44788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0085-2008
  • Event Initiated Date
    2007-08-02
  • Event Date Posted
    2007-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64369
  • 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
    hip prosthesis - Product Code KWY
  • Reason
    Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
  • Action
    Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.

Device

Foundation Hip System Bipolar Modular
  • Model / Serial
    Lot #: 679631, 678531, 678541, 678551, 678561, 678571, 691661, 692771, 692761, 694351, 694401, 694411, 694421, 698261, 695131, 695911, 697781, 730131, 731451, 731461, 731471, 205452, 736421, 770051, 770061, 770071, 770181, 780151, 783921, 788361, 792671, 794391, 811171, 811181, 811191, 811201, 811291, 832281, 832291, 835521, 842301, 842311, 848671, 854501, 854511, 854981, 874961, 874971, 874981, 882591, 882601, 893581, 893591, 893601, 893611, 903141, 903151, 905561, 925731, 925741, 925751, 927231, 932711, 932721, 933761, 933771, 933781, 944261, 944271, 949411, 949421, 964211, 964221, 964231 and 964241.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Greece, Japan, and Saudi Arabia.
  • Product Description
    Foundation¿ Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA