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U.S. Department of Health and Human Services

Class 3 Device Recall PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV)

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  Class 3 Device Recall PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV) see related information
Date Initiated by Firm October 26, 2011
Date Posted November 23, 2011
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-0274-2012
Recall Event ID 60328
510(K)Number K041669  
Product Classification Mesh, surgical - Product Code FTM
Product 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
Code Information Lot # 5784583-1590912
Recalling Firm/
Manufacturer		 Synovis Surgical Inovation Div. of
2575 University Ave W
Saint Paul MN 55114-1073
For Additional Information Contact
651-603-3700
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Labeling mix-ups
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.
Quantity in Commerce 132 units
Distribution Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.
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.
510(K) Database 510(K)s with Product Code = FTM and Original Applicant = SYNOVIS SURGICAL INNOVATIONS
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