Events

Recall of PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV)

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
    60328
  • Event Risk Class
    Class 3
  • Event Number
    Z-0274-2012
  • Event Initiated Date
    2011-10-26
  • Event Date Posted
    2011-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105039
  • 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
    Synovis surgical innovations is voluntarily recalling one lot of peri-strips dry with veritas collagen matrix staple line reinforcement (psd-v) product because some of the devices were mislabeled.
  • Action
    Synovis Surgical Inovation sent a "Recall Notification" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.

Device

PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV)
  • Model / Serial
    Lot # 5784583-1590912
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.
  • Product Description
    Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024. || The device is intended to be used as a staple line buttress
  • 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