Events

Recall of Device Recall ORTHOCORD One Violet and One Blue Braided Composite Suture with OS6 Reverse Cutting Needles

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
    64706
  • Event Risk Class
    Class 2
  • Event Number
    Z-1176-2013
  • Event Initiated Date
    2013-03-22
  • Event Date Posted
    2013-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116836
  • 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
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Reason
    The ifu provided with the free strand orthocord sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. while this statement is true for violet orthocord sutures, it is an inaccurate statement for blue orthocord free strand sutures. based on in-vivo strength retention study, a blue orthocord sutures maintain approximately 80% of strength at six.
  • Action
    On March 22, 2013, firm notified consignees of recall via letter. Consignees were informed of the following: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. As Blue and Violet ORTHOCORD free strand sutures share the same IFU, IFU-108147 will be revised. Consignees were requested to confirm the receipt of the letter by March 29, 2013.

Device

Device Recall ORTHOCORD One Violet and One Blue Braided Composite Suture with OS6 Reverse Cuttin...
  • Model / Serial
    ALL from Jan 1 2010 - Corrected IFU implementation date
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. || For use in general soft tissue approximation, and/or ligation, including 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