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-0962-2007
• 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 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
• Code Information: 5713060-221868, 5713061-221869, 5714567-250264, 5712862-215844, 5715407-268139, 5717353-310944-001, 5717354-310947-002, 5717355-310948-003, 5717356-310950-004, 5717357-310951-005, 5717358-310953-006, 5717359-310954-007, 5717360-310955-008, 5717361-310956-009, 5717362-310957-010, 5717403-311742-017, 5717404-311743-018, 5717405-311744-019 , 5717406-311745-020, 5717407-311746-021, 5717408-311747-022, 5717409-311748-023, 5717410-311749-024, 5717411-311750-025, 5717412-311751-026, 5717413-311752-027, 5717414-311753-028, 5717415-311754-029, 5717416-311755-030, 5717397-311734-011, 5717398-311737-012, 5717399-311738-013, 5717400-311739-014, 5717401-311740-015, 5717402-311741-016, 5717417-311756-031, 5717418-311757-032, 5717578-314896-033, 5717579-314897-034, 5716064-280283, 5716065-280284, 5717580-314898-035, 5717581-314999-036, 5717582-314901-037, 5717583-314902-038, 5717584-314903-039, 5717585-314904-040, 5717586-314905-041, 5717587-314906-042, 5717588-314907-043, 5717589-314908-044, 5713061-396028, 5713061-396088, 5714567-395788, 5714567-396037, 5714567-396041, 5714567-396047, 5714567-396085, 5714567-396831, 5714567-408289, 5716453-285027. EXPANDED LOT/SERIAL #'s: 5716453-285027, 5716453-577195.
• 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: 138
• 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