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U.S. Department of Health and Human Services

Class 2 Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV)

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  Class 2 Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV) see related information
Date Initiated by Firm March 16, 2007
Date Posted June 15, 2007
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0965-2007
Recall Event ID 37671
510(K)Number K041669  
Product Classification Surgical Mesh - Product Code FTM
Product Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
Code Information 5713059-221867, 5713425-227244, 5717618-314939-001, 5717619-314940-002, 5717620-314941-003,  5717621-314942-004, 5717622-314943-005,  5717623-314944-006, 5717624-314945-007,  5717625-314946-008, 5717626-314947-009,  5717627-314948-010, 5713059-301281, 5713425-332644, 5713425-332648, 5713425-395826. EXPANDED SERIAL/LOT#: 5716063-280282
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		 Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
FDA Determined
Cause 2		 Other
Action Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.
Quantity in Commerce 86
Distribution Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
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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