Events

Recall of Norian Drillable

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

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
    79043
  • Event Risk Class
    Class 2
  • Event Number
    Z-0617-2018
  • Event Initiated Date
    2017-08-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161228
  • 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
    Calcium salt bone void filler, drillable, non-screw augmentation - Product Code OIS
  • Reason
    The contract supplier notified depuy synthes on june 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. some kit expiration dates were later than the earliest expiration date of the component lots. the expiration dates of some components are earlier than that listed on the kit.
  • Action
    On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited.

Device

Norian Drillable
  • Model / Serial
    Product Number: 07.704.003S Lot Number: DSD9110
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Norian Drillable Inject
  • Manufacturer
    Synthes USA

Manufacturer

Synthes USA
  • Manufacturer Address
    Synthes USA, 1230 Wilson Dr, West Chester PA 19380-4231
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA