FDA Recall Terminated

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

Recall: Z-0891-05 · Initiated May 23, 2005

Recall

Recall Number: Z-0891-05
Event Number: 32264
Firm: Synovis Surgical Inovation Div. of
FEI Number: 2183620
Product Code: FTM
Status: Terminated
Root Cause: Other
Initiated: May 23, 2005
Posted: June 14, 2005
Terminated: November 17, 2005
Address: 2575 University Ave W, Saint Paul, MN, 55114-1073

Description

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.

Distribution

AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA

Quantity

320 boxes each box containing 6 pouches