Recall of Synthes small Electric Drive (SED)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Anspach Effort, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Pliers, surgical - Product Code HTC
  • Reason
    The affected small electric drive (sed) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
  • Action
    On 11/13/2014 DePuy Synthes send a letter to all their customers informing them of the recall of all the lots of the Small Electric Drive (SED) with instructions to returned and possible exchange. Contact is Complaint Handling Unit Manager at 561-494-3673


  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.
  • Product Description
    Synthes Small Electric Drive (SED). For use in general traumatology.
  • Manufacturer


  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
  • Source