Events

Recall of Synthes

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
    55438
  • Event Risk Class
    Class 2
  • Event Number
    Z-1804-2010
  • Event Initiated Date
    2010-04-01
  • Event Date Posted
    2010-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90859
  • 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
    Orthopedic manual surgical instrument, Medullary Tubes - Product Code LXH
  • Reason
    After repeated sterilizations product may become discolored and break including while in the medullary canal. synthes has determined that the medullary tube will be a single use item that is to be discarded after one sterilization cycle.
  • Action
    The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter. Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant.

Device

Synthes
  • Model / Serial
    Catalog number 355.01. all lot numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide.
  • Product Description
    Synthes Medullary Tubes
  • 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