Events

Recall of Device Recall DePuy Mitek Bioknotless Anchor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Depuy Mitek, 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
    34684
  • Event Risk Class
    Class 3
  • Event Number
    Z-0610-06
  • Event Initiated Date
    2006-02-17
  • Event Date Posted
    2006-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44465
  • 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
    Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
  • Reason
    The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
  • Action
    Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.

Device

Device Recall DePuy Mitek Bioknotless Anchor
  • Model / Serial
    Lot Number: 1358481 Exp Date: Nov 2008
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Depuy Mitek Bioknotless Anchor with Ethibond Suture || Ref No. 212728
  • Manufacturer
    Depuy Mitek, a Johnson & Johnson Co.

Manufacturer

Depuy Mitek, a Johnson & Johnson Co.
  • Manufacturer Address
    Depuy Mitek, a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767-5199
  • Source
    USFDA