Events

Recall of Device Recall Synthes Power Drive.

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

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
    49039
  • Event Risk Class
    Class 2
  • Event Number
    Z-2395-2008
  • Event Initiated Date
    2008-07-23
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72569
  • 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
    Motor, surgical instrument, ac-powered - Product Code GEY
  • Reason
    The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. the currently validated sterilization parameter is a minium of 24 minutes prevacuum.
  • Action
    All Synthes Trauma customers and sales consultant s were notified of the correction via return receipt letters sent via UPS. This notification communication contains product literature documenting the validated sterilization parameters. Instructions detail disposal of the previously received literature and replacement with the provided literature. A toll free number with a dedicated extension has been established for questions. The firm has requested that all recipients acknowledge understanding of instructions by returning a Verification Section via fax or email. If you have questions, call 800-620-7025 ext 5450, 610-719-5450 or contact your Synthes Sales Consultant.

Device

Device Recall Synthes Power Drive.
  • Model / Serial
    Catalog number 530.100. All lot numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
  • Product Description
    Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
  • Manufacturer
    Synthes U S A

Manufacturer

Synthes U S A
  • Manufacturer Address
    Synthes U S A, 1302 Wrights Ln, West Chester PA 19380-3401
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA