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U.S. Department of Health and Human Services

Class 2 Device Recall Synovis PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement

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  Class 2 Device Recall Synovis PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement see related information
Date Initiated by Firm May 23, 2005
Date Posted June 14, 2005
Recall Status1 Terminated 3 on November 17, 2005
Recall Number Z-0891-05
Recall Event ID 32264
510(K)Number K041699  
Product Classification Mesh, Surgical - Product Code FTM
Product 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
Code Information Lot Number: 5707464-166925, 5707598-118352, 5708605-151644, 5708622-152524, 5708624-152526, 5709355-167627, 5709825-173142, 5709826-173143 and 5709827-173144
Recalling Firm/
Manufacturer		 Synovis Surgical Inovation Div. of
2575 University Ave W
Saint Paul MN 55114-1073
For Additional Information Contact Mary Frick
651-603-3700
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 320 boxes each box containing 6 pouches
Distribution AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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