Events

Recall of Device Recall DePuy Mitek FMS Irrigation Intermediary Tube Without Oneway Valve Arthroscopy tubing

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
    57385
  • Event Risk Class
    Class 2
  • Event Number
    Z-1948-2011
  • Event Initiated Date
    2010-12-03
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98756
  • 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 HBX
  • Reason
    Product sterility may be compromised due to breach in sterile packaging.
  • Action
    Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.

Device

Device Recall DePuy Mitek FMS Irrigation Intermediary Tube Without Oneway Valve Arthroscopy tubing
  • Model / Serial
    Lot Codes: 1060789 1060823 1060838 1060848 1061291 1061292 BBBA1001I BBBA1003D BBBA1003E BBBA1004A BBBA1006F BBBA1007D BBBA1008A BBBA1010A BBBA1011D BBBA1014B BBBA1015R BBBA1018G BBBA1019E
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.
  • Product Description
    DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) || (International Distribution Only) || Product Code: 281102 || Fluid Tissue Management
  • 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