Events

Recall of Device Recall Synovis PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synovis Surgical Inovation Div. of.

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
    32264
  • Event Risk Class
    Class 2
  • Event Number
    Z-0891-05
  • Event Initiated Date
    2005-05-23
  • Event Date Posted
    2005-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39470
  • 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
    Mesh, Surgical - Product Code FTM
  • Reason
    Device is contained in 2 pouches. the outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.
  • Action
    The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return.

Device

Device Recall Synovis PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement
  • Model / Serial
    Lot Number: 5707464-166925, 5707598-118352, 5708605-151644, 5708622-152524, 5708624-152526, 5709355-167627, 5709825-173142, 5709826-173143 and 5709827-173144
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA
  • Product Description
    Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627
  • Manufacturer
    Synovis Surgical Inovation Div. of

Manufacturer

Synovis Surgical Inovation Div. of
  • Manufacturer Address
    Synovis Surgical Inovation Div. of, 2575 University Ave W, Saint Paul MN 55114-1073
  • Source
    USFDA