{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105039", "product_res_number": "Z-0274-2012", "event_date_initiated": "2011-10-26", "event_date_posted": "2011-11-23", "recall_status": "Terminated", "event_date_terminated": "2012-04-24", "res_event_number": "60328", "product_code": "FTM", "k_numbers": [ "K041669" ], "product_description": "Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024.\n\nThe device is intended to be used as a staple line buttress", "code_info": "Lot # 5784583-1590912", "firm_fei_number": "2183620", "recalling_firm": "Synovis Surgical Inovation Div. of", "address_1": "2575 University Ave W", "city": "Saint Paul", "state": "MN", "postal_code": "55114-1073", "additional_info_contact": "651-603-3700", "reason_for_recall": "Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.", "root_cause_description": "Labeling mix-ups", "action": "Synovis Surgical Inovation sent a \"Recall Notification\" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.", "product_quantity": "132 units", "distribution_pattern": "Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.", "openfda": { "k_number": [ "K112423", "K940205", "K011025", "K182259", "K062915", "K201000", "K971048", "K991567", "K050246", "K192452", "K831726", "K122048", "K852011", "K113460", "K141053", "K034039", "K182255", "K030782", "K922308", "K110581", "K082682", "K896946", "K844225", "K161221", "K062696", "K060829", "K081272", "K071065", "K830889", "K831727", "K083039", "K140306", "K013625", "K071807", "K031969", "K200311", "K021107", "K961811", "K071016", "K110402", "K140501", "K142070", "K051048", "K173242", "K052322", "K141721", "K162752", "K040835", "K063178", "K894580", "K061892", "K160181", "K082687", "K040364", "K053655", "K183472", "K831725", "K021105", "K213163", "K120605", "K023237", "K062729", "K150668", "K172937", "K070560", "K170016", "K203496", "K142326", "K043388", "K923657", "K081882", "K041140", "K132025", "K062320", "K820619", "K083823", "K162554", "K250598", "K094061", "K162461", "K243595", "K980431", "K062558", "K041669", "K053562", "K061030", "K083898", "K020049", "K233991", "K844228", "K063556", "K201313", "K123356", "K170763", "K192616", "K040119", "K141084", "K040756", "K060984", "K020455", "K040868", "K103787", "K120019", "K963175", "K983162", "K160869", "K091142", "K162965", "K134033", "K031332", "K080452", "K073391", "K183398", "K150712", "K241126", "K040621", "K162934", "K043259", "K973379", "K152206", "K992537", "K851086", "K071986", "K101587", "K214070", "K082176", "K070738", "K042809", "K142887", "K133306", "K070405", "K011027", "K162570", "K162388", "K213125", "K112786", "K182493", "K171817", "K111436", "K111584", "K060989", "K081538", "K982330", "K130547", "K831723", "K041923", "K090880", "K915774", "K091499", "K203600", "K192615", "K153633", "K991296", "K073219", "K051879", "K001738", "K050337", "K223052", "K961810", "K021056", "K033985", "K090778", "K021160" ], "device_name": "Mesh, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2", "registration_number": [ "", "1526534", "1835959", "2245304", "1000393132", "3018094310", "3012358417", "8010177", "3010400367", "3012102437", "2530154", "9615742", "3005497913", "9617465", "3012669262", "3015531529", "3009417901", "3015413883", "3013820501", "2249852", "3010513348", "1818910", "3004170064", "9680579", "3010600625", "1647098", "3007321028", "1213643", "3008812560", "1220477", "3014461810", "2124215", "3010155661", "2246552", "3027383505", "3013666218", "1820334", "2132242", "3003604053", "3002719998", "3005636544", "3005619880", "9614442", "3016429246", "3004681519", "2023811", "3016003911", "2183744", "2183620", "1048735", "3003300673", "3005920706", "3000215346", "3027448274", "3003936139", "3036710971", "3016823837", "8043792", "3009493875", "3002807561", "1121308", "3004464325", "3009039068", "3014003617", "2244478", "3006017180", "3010178296", "1649390", "1111225", "3012547639", "1416980", "1221816", "2030598", "3008868758", "3012448339", "1047843", "3003418325", "3013307971", "3009882464", "1319660", "1220948", "1550222", "3002924436", "1018233", "3010894343", "3009504230", "1018470", "1450662", "2024024", "3015543569", "3000931034" ], "fei_number": [ "", "3000718467", "1526534", "2245304", "1000518731", "1000393132", "3018094310", "3002340648", "3012358417", "1000306051", "3010400367", "3012102437", "1000143837", "3005497913", "3012669262", "3015531529", "3003769549", "3009417901", "3015413883", "3013820501", "3010513348", "1818910", "3004170064", "3003870583", "1000203464", "3010600625", "3007321028", "1213643", "1000148471", "1000307073", "3008812560", "1220477", "3014461810", "2124215", "3010155661", "2246552", "3027383505", "3013666218", "1820334", "3002719998", "3003604053", "3005636544", "3005619880", "3002821504", "3016429246", "2023811", "1000136269", "3016003911", "2183744", "2183620", "3003521774", "1048735", "3003300673", "3005920706", "3000215346", "3027448274", "3003936139", "3036710971", "3016823837", "3008817245", "3009493875", "3002807561", "1121308", "3009039068", "3004464325", "3014003617", "3006017180", "1111225", "3012547639", "1416980", "3003110073", "3008868758", "3000303710", "3012448339", "1047843", "3003418325", "3013307971", "3009882464", "1220948", "3002808269", "1550222", "3002924436", "1018233", "3010894343", "3009504230", "1018470", "1450662", "2024024", "3015543569", "1000136478", "3000931034" ] } } ] }