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Medical Device Recalls
Class 2 Recall
Petri-Strips Dry with Veritas Collagen Matrix (PSD-V)
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Date Recall
Initiated |
March 16, 2007
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| Date Posted |
June 15, 2007
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| Recall Number |
Z-0962-2007
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| 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
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| 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.
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Recalling Firm/
Manufacturer |
Synovis Surgical Inovation Div. of
2575 University Ave W
Saint Paul
, Minnesota
55114-1073
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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.
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| 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.
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| Quantity in Commerce |
138
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| 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
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