Events

Recall of Device Recall HemoLokSMX Legating Clip

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

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
    28248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0547-04
  • Event Initiated Date
    2004-01-23
  • Event Date Posted
    2004-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31441
  • 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
    Malformation of the hem-o-lok smx clip.
  • Action
    Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.

Device

Device Recall HemoLokSMX Legating Clip
  • Model / Serial
    Catalog number 544220, Lot number 988384
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France
  • Product Description
    Hem-o-Lok¿SMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems¿, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.
  • Manufacturer
    Weck

Manufacturer

Weck
  • Manufacturer Address
    Weck, 1 Weck Dr., Research Triangle Park NC 27709
  • Source
    USFDA