Events

Recall of Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap Implant Systems LLC.

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
    62240
  • Event Risk Class
    Class 2
  • Event Number
    Z-1934-2012
  • Event Initiated Date
    2012-03-07
  • Event Date Posted
    2012-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110004
  • 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
    Countersink - Product Code HWW
  • Reason
    Aesculap implant systems, llc has initiated a voluntary removal of the s4 cervical (s4c) occiput revision instrument that is part of the s4c occipital instrument set. the instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
  • Action
    The firm initiated their recall of this product by issuing an "Important Product Removal Notification" letter to all consignees dated March 7, 2012. The letter described the problem, advised them not to use the product, and instructed consignees to return the instruments to the recalling firm with the attached Distribution Inventory Sheet. Customer Service may be contacted if questions at 1-866-229-3002.

Device

Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R)
  • Model / Serial
    All distributed lot numbers and serial numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
  • Product Description
    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

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