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

• Date Initiated by Firm: March 16, 2007
• Date Posted: June 15, 2007
• Recall Status: Terminated on February 24, 2008
• Recall Number: Z-0963-2007
• 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 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
• Code Information: 5713057-221865, 5713421-227240, 5727945-538783, 5728518-547271. EXPANDED SERIAL/LOT#'s: 5728518-560761 and 5729324-562206
• 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: 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: 85
• 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