Events

Recall of Device Recall Dafilon Suture

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
    68607
  • Event Risk Class
    Class 2
  • Event Number
    Z-2024-2014
  • Event Initiated Date
    2014-06-13
  • Event Date Posted
    2014-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128304
  • 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
    Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
  • Reason
    Aesculap inc. (aic (usa)) has initiated a voluntary recall of dafilon black 10/0 (0.2) 15 cm drm4 non-sterile non-absorbable polyamide surgical suture due to a labeling issue. box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
  • Action
    A correction and removal notification, dated June 13, 2014, was sent to end users, sales reps, and distributors which described the product, problem, and actions to be taken.

Device

Device Recall Dafilon Suture
  • Model / Serial
    Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of IL, NY, GA, and RI.
  • Product Description
    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
  • 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