Events

Recall of Device Recall Bayonet Electrosurgical Pencil

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zinnanti Surgical Design 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
    38458
  • Event Risk Class
    Class 2
  • Event Number
    Z-1150-2007
  • Event Initiated Date
    2007-07-12
  • Event Date Posted
    2007-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53803
  • 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
    Bayonet Electrosurgical Pencil - Product Code GEI
  • Reason
    Bubble leak test failure of sterility barrier, therefore sterility of the device may be compromised.
  • Action
    The recalling firm issued an Urgent Medical Device Recall Letter dated 7/24/07 to its single wholesaler requesting recall and sub-recall to all their consignees.

Device

Device Recall Bayonet Electrosurgical Pencil
  • Model / Serial
    Product Number 9560575-900. Lot numbers 3003-1, 111805, 182275, 182280, 182290, 182300, 182310, 182320, 182330, and 182340.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.
  • Manufacturer
    Zinnanti Surgical Design LLC

Manufacturer

Zinnanti Surgical Design LLC
  • Manufacturer Address
    Zinnanti Surgical Design LLC, 42 Forest Ave, Hershey PA 17033-2018
  • Source
    USFDA