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U.S. Department of Health and Human Services

Class 2 Device Recall PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV)

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  Class 2 Device Recall PeriStrips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV) see related information
Date Initiated by Firm November 01, 2005
Date Posted April 13, 2006
Recall Status1 Terminated 3 on February 03, 2007
Recall Number Z-0764-06
Recall Event ID 34052
510(K)Number K041669  
Product Classification Mesh, Surgical - Product Code FTM
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Synovis Surgical Inovation Div. of
2575 University Ave W
Saint Paul MN 55114-1073
For Additional Information Contact Mary L. Frick
651-796-7317
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 4,950
Distribution Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and 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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