Events

Recall of Device Recall Aesculap SIBD 4 degree Trial Implant (SJ768TUS) and Aesculap SIBD 9 degree Trial Implant (SJ780TUS

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
    62626
  • Event Risk Class
    Class 2
  • Event Number
    Z-2114-2012
  • Event Initiated Date
    2012-07-12
  • Event Date Posted
    2012-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111198
  • 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
    Template - Product Code HWT
  • Reason
    The 4 degree and 9 degree trial instruments (sj768t-us/sj780t-us) are correctly dimensioned, but the part number etched on the instrument may be incorrect. the 4 degree trial instrument (sj768t-us) may be marked with the incorrect part number of the 9 degree trail instrument (sj780t-us) and the 9 degree trial instrument (sj780t-us) may be marked with the incorrect part number of the 4 degree tria.
  • Action
    Aesculap sent an Important Product Removal Notification letter dated July 11, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product by contacting their local sales representative or the customer service department at 1-866-229-3002 for a Returned Goods Request )RGR) number. Customers were asked to complete and return the Distribution Inventory Sheet. For questions call 610-984-9260 or 610-984-9274.

Device

Device Recall Aesculap SIBD 4 degree Trial Implant (SJ768TUS) and Aesculap SIBD 9 degree Trial I...
  • Model / Serial
    4 degree - SJ768T-US and 9 degree SJ780T-US
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - including the states of CO, OH, OK and TX.
  • Product Description
    Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) || Product Usage: || The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
  • 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