Events

Recall of Bone Wax

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    50132
  • Event Risk Class
    Class 2
  • Event Number
    Z-0992-2009
  • Event Initiated Date
    2008-10-28
  • Event Date Posted
    2009-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74800
  • 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 Wax - Product Code MTJ
  • Reason
    A hospital reported to their ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. upon investigation, this box was determined to be missing from a shipment between two steps of the manufacturing process. further checks determined that two other boxes were missing.
  • Action
    Letters were sent via UPS next day air on October 28, 2008 to all customers who purchased finished product codes W31G and DW31B (on inner box labels) from January 1, 2008 through October 22, 2008.

Device

Bone Wax
  • Model / Serial
    Product code: W31; Lot # AG089. W31 is the product code for unfinished product. AG089 is the lot number assigned by Sharp Corp.  DW31B is assigned on the inner box labels.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Bone Wax. || Ethicon, Inc. || Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. || The device is indicated for use to control bleeding from the bone surface during surgical procedures.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA