Events

Recall of Device Recall VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Mitek, Inc., a Johnson & Johnson Co..

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
    63283
  • Event Risk Class
    Class 2
  • Event Number
    Z-0133-2013
  • Event Initiated Date
    2012-03-12
  • Event Date Posted
    2012-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113405
  • 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
    Electrosurgical, cutting; coagulation; accessories - Product Code GEI
  • Reason
    Product may have wrong large product identification label with symbols on the box indicating a s90 vapr electrode instead of the vapr 3.5 hook electrode.
  • Action
    The firm, Depuy Mitek, sent a "Medical Device Labeling Alert" letter dated March 14, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory to determine if any inventory of product code 227305 lot with the number M1108086 that is incorrectly labeled; review the following label information and the attached examples of correct and incorrect labels; and complete and return the Business Reply Form via fax to: 1-508-828-3750. To return the product call 1-877-379-4871 for an RGA and replacement product and return to DePuy Mitek, Attn: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324. Contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-48

Device

Device Recall VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece
  • Model / Serial
    Lot Number: M1108086
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, NJ, NY, OH, OR, TN, TX, UT, VA, and WA.
  • Product Description
    DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece || Catalog Number: 227305 || The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • Manufacturer Address
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA