Events

Recall of Device Recall WECK EFX" Shield

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

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
    75693
  • Event Risk Class
    Class 2
  • Event Number
    Z-0759-2017
  • Event Initiated Date
    2016-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151062
  • 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
    Instrument, ligature passing and knot tying - Product Code HCF
  • Reason
    The devices wings may become partially detached from the efx shield during use.
  • Action
    Consignees were notified via letter on 11/16/2016.

Device

Device Recall WECK EFX" Shield
  • Model / Serial
    Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Domestic; US Nationwide; International: Belgium, Canada.
  • Product Description
    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA