Events

Recall of Device Recall Davol Composix Kugel Hernia Patch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Davol, Inc., Sub. C. R. Bard, 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
    36990
  • Event Risk Class
    Class 1
  • Event Number
    Z-0360-2007
  • Event Initiated Date
    2007-01-10
  • Event Date Posted
    2007-01-30
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49722
  • 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
    Hernia Patch - Product Code FTL
  • Reason
    Pet recoil ring breakage-memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula.
  • Action
    Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.

Device

Device Recall Davol Composix Kugel Hernia Patch
  • Model / Serial
    Lot Numbers: 43AOD 43LOD  43BOD 43APD  43COD 43BPD  43DOD 43CPD  43EOD 43DPD  43FOD 43EPD  43GOD 43FPD  43HOD 43GPD  43IOD 43HPD 43JOD 43IPD  43KOD; Market Withdrawal: 43JPD 43DQD  43KPD 43EQD  43LPD 43FQD 43AQD 43GQD  43BQD 43HQD  43CQD 43IQD* *Redesigned products will be clearly indicated on the  label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Bard Composix Kugel Hernia Patch- || Large Circle 4.5'' with ePTFE || Product Code: 0010204
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Sub. C. R. Bard, Inc.
  • Manufacturer Address
    Davol, Inc., Sub. C. R. Bard, Inc., 100 Sockanossett Crossroad, Cranston RI 02920
  • Source
    USFDA