Events

Recall of Device Recall 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
    34052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0764-06
  • Event Initiated Date
    2005-11-01
  • Event Date Posted
    2006-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43017
  • 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
    The peri-strips dry with veritas collagen matrix staple line reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.
  • Action
    An initial phone call was placed to expedite return and replacement of product. A follow-up letter was sent. The initial phone calls to customers began on November 1, 2005.

Device

Device Recall PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV)
  • Model / Serial
    Lot number: 5710119-175140, 5710790-180727, 5710941-181455, 5710942-181456, 5711046-181820, 5711047-18121, 5711227-183395, 5711397-185711, 5711448-186781, 5711724-190560, 5711777-191665, 5711930-194095, 5712202-197704, 5712203-197705, 5712254-198709, 5712255-198710, 5712256-198711, 5712965-220245, 5713055-221862, 5713056-221864, 5713059-221867, 5713060-221868, 5713061-221869, 5713261-225636, 5713419-227238, 5713420-227239, 5713657-230645, 5713658-230646, 5713789-235178, 5714079-239059, 5714507-246886, 5714566-247028, 5714665-252591, and 5714901-255263. Six pouches of unknown lot number hand carried to the University of Chicago as well as 12 pouches to the University of Missouri.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and VA
  • Product Description
    Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 2575 University Ave. W., St. Paul, MN 55114-1024 USA.
  • 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