Events

Recall of ALFA II Modular Femoral Right Modular Stem

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
    37881
  • Event Risk Class
    Class 2
  • Event Number
    Z-1066-2007
  • Event Initiated Date
    2007-04-12
  • Event Date Posted
    2007-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52046
  • 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 replacement prosthesis component - Product Code JDI
  • Reason
    Sterility/package integrity: device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
  • Action
    Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.

Device

ALFA II Modular Femoral Right Modular Stem
  • Model / Serial
    Lot #Y132E and 1830A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product distributed to surgical centers in CT, KS and MO.
  • Product Description
    ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; distributed 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