Events

Recall of Device Recall Axillent Debakey Grasping Forceps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karl Storz Endoscopy America 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
    66823
  • Event Risk Class
    Class 2
  • Event Number
    Z-0465-2014
  • Event Initiated Date
    2013-11-06
  • Event Date Posted
    2013-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123575
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Reason
    Karl storz is recalling the axillent debakey grasping forceps because the 33821wtd wavy grasper was mislabeled as 33821dyd axillent debakey grasping forceps.
  • Action
    Karl Storz Endosocopy sent a Safety Alert letter dated November 6, 2013, to all customers who received the 33821DYD Axillent Debakey Grasping Forceps. The letter informed the customers of the problems identified and the actions to be taken. Customers were asked to set aside the mislabeled product and return the mislabeled instruments with the RMA (Return Material Authorization) number issued to them. Customers were instructed to fax or email completed recall response form to (424) 218-8519. Customers with any questions were instructed to call (800) 421-0837 ext 8289. For questions regarding this recall call 746-708-8440.

Device

Device Recall Axillent Debakey Grasping Forceps
  • Model / Serial
    Lot Code YX
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of: TX, PA, and NY.
  • Product Description
    Axillent Debakey Grasping Forceps, Part No. 33821DYD || In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 15 Wells St, Southbridge MA 01550-4503
  • Manufacturer Parent Company (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA