Events

Recall of Device Recall Simplex P

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    36871
  • Event Risk Class
    Class 2
  • Event Number
    Z-0467-2007
  • Event Initiated Date
    2006-11-07
  • Event Date Posted
    2007-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49480
  • 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
    Bone Cement - Product Code MBB
  • Reason
    The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. the external label provides for an incorrect longer expiration date than the actual subcomponents will support.
  • Action
    A recall notification was sent by Federal Express on 11/7/06. The firm will follow-up with telephone calls and follow-up letters as necessary.

Device

Device Recall Simplex P
  • Model / Serial
    Lot Code MBN003, catalog no. 6197-9-010 (10 pk) Lot Code MBN003, catalog no. 6197-9-001 (1 pk) Lot Code MBN004; catalog no. 6197-9-010 (10 pk) Lot code MBN004; catalog no. 6197-9-001 (1 pk)  Lot Code MBN003 and MBN004 - powder ''use by'' date 12/2007  Lot Code MBN003 and MBN004 - liquid ''use by'' date 9/2006  Product ''Use By'' Date: September 2006
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA