Events

Recall of Norian CRS Rotary Mixer Cement 10cc sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA (HQ), 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
    53496
  • Event Risk Class
    Class 2
  • Event Number
    Z-0269-2010
  • Event Initiated Date
    2009-09-14
  • Event Date Posted
    2009-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85637
  • 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
    Methyl Methacrylate For Cranioplasty - Product Code GXP
  • Reason
    Non-conforming material - increased set time. potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. the risk of norian fragmentation post cure increases with a larger defect and a thicker layer of product. customers were advised to call synthes at 1-800-479-6329 to obtain a return autho.
  • Action
    The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.

Device

Norian CRS Rotary Mixer Cement 10cc sterile
  • Model / Serial
    Catalog number 614.10.01S. Lot number N996352
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
  • Product Description
    Norian CRS Rotary Mixer Cement 10cc sterile
  • Manufacturer
    Synthes USA (HQ), Inc.

Manufacturer

Synthes USA (HQ), Inc.
  • Manufacturer Address
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA