Events

Recall of Device Recall S4C Occiput Torque Wrench F/Set Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap, 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
    71709
  • Event Risk Class
    Class 2
  • Event Number
    Z-2326-2015
  • Event Initiated Date
    2015-07-07
  • Event Date Posted
    2015-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138797
  • 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
    Wrench - Product Code HXC
  • Reason
    A fw103r torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. the firm did not include instructions for reassembly after reprocessing.
  • Action
    Aesculap sent Field Safety Notification Letters, dated July 7, 2015, to end users, sales consultants, and distributors to advise them about the issue. Enhancements to the instructions for use were made available on the firm's website.

Device

Device Recall S4C Occiput Torque Wrench F/Set Screw
  • Model / Serial
    product: FW103R, all Lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and to Canada.
  • Product Description
    S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA