Events

Recall of Device Recall DS Titanium Ligation Clip

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
    79530
  • Event Risk Class
    Class 2
  • Event Number
    Z-1290-2018
  • Event Initiated Date
    2018-01-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162596
  • 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
    Clip, implantable - Product Code FZP
  • Reason
    Added a contraindication to ifu: do not use the ds clips for living donor nephrectomies. added other contraindications. a publication from 2017 recommended aesculap ds clips for kidney transplantation with living donors. the information from this publication was not approved or validated by the firm.
  • Action
    A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned. IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use.

Device

Device Recall DS Titanium Ligation Clip
  • Model / Serial
    DS Clips - Product Numbers PL450SU DS SINGLE FIRE LIG.CLIPS PL471SU DS SINGLE FIRE LIG.CLIP L W/LATCH PL453SU DS SINGLE FIRE LIG.CLIP SM PL475SU DS SINGLE FIRE LIG.CLIP XL W/LATCH PL459SU DS SINGLE FIRE LIG.CLIP M PL462SU DS SINGLE FIRE LIG.CLIP ML PL465SU DS SINGLE FIRE LIG.CLIP ML W/LATCH PL468SU DS SINGLE FIRE LIG.CLIP L (all clips going back 5 years)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US and Canada distribution
  • Product Description
    DS Titanium Ligation Clip, used in laparoscopic 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