Events

Recall of Device Recall Hemostatic Bone Putty

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, 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
    70055
  • Event Risk Class
    Class 2
  • Event Number
    Z-1094-2015
  • Event Initiated Date
    2012-01-06
  • Event Date Posted
    2015-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132283
  • 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
    Wax,bone - Product Code MTJ
  • Reason
    Revision a of the hemostatic bone putty brochure (j10847a) was sent to sales consultants instead of revision b (j10847b), which corrected an error in the indication statement.
  • Action
    On/about 12/22/2011, emails containing Revision B brochure, as well as instructions to delete/destroy Revision A, were sent to 38 affected individuals (sales consultants). On/about 1/04/2012, follow up phone calls were made to each member of the sales force who had received Rev. A (110847 A) to confirm that they had replaced the Rev. A with the Rev. B (110847 B). In addition, the members of the sales force were asked whether or not the Rev. A had been disseminated to any HCP's. During the follow up conversation, one member of the sales force stated that he had provided the previous version to a surgeon. On 01/06/2012, the sales consultant spoke to the surgeon in person and the surgeon confirmed that he had disposed of the Rev. A.

Device

Device Recall Hemostatic Bone Putty
  • Model / Serial
    Part 10847A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    Distributed in the state of WI
  • Product Description
    Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
  • Manufacturer
    Synthes, Inc.

Manufacturer

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