Events

Recall of Device Recall FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

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
    72697
  • Event Risk Class
    Class 2
  • Event Number
    Z-0657-2016
  • Event Initiated Date
    2015-11-20
  • Event Date Posted
    2016-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141993
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Product is incorrectly labeled. the blade configuration in the affected lots does not match the description on the label.
  • Action
    On November 20, 2015, customers were notified of the recall via letter. They were asked to take the following actions: Customer immediate actions: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located within your facility; 2. Review, complete, sign and return the attached business reply form to Elizabeth Messana (emessan1@its.jnj.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification; 3. Forward this notice to anyone in your facility that needs to be informed; 4. If any potentially affected product has been forwarded to another facility, contact Elizabeth Messana at 508-828-3150; 5. Keep a copy of this notice.

Device

Device Recall FMS neXtra 3.5mm Aggressive Cutter Shaver Blades
  • Model / Serial
    Lot Number: M1505053
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.
  • Product Description
    FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 || Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
  • 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 Drive, Raynham MA 02767-5199
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA