{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "39471", "product_res_number": "Z-0892-05", "event_date_initiated": "2005-05-23", "event_date_posted": "2005-06-14", "recall_status": "Terminated", "event_date_terminated": "2005-11-17", "res_event_number": "32264", "product_code": "FTM", "product_description": "Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627", "code_info": "lot number: 5707471-116932, 5707579-118319 and 5709356-167628.", "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": "Mary Frick\n651-603-3700", "reason_for_recall": "Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.", "root_cause_description": "Other", "action": "The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return.", "product_quantity": "56 boxes each box containing 6 pouches", "distribution_pattern": "AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA", "openfda": { "k_number": [ "K170763", "K820619", "K081272", "K192616", "K992537", "K041923", "K142887", "K961810", "K043388", "K063178", "K140501", "K971048", "K160181", "K062729", "K091499", "K063556", "K060989", "K213163", "K050246", "K233991", "K031969", "K162752", "K061892", "K090880", "K112423", "K113460", "K162934", "K153633", "K831723", "K023237", "K162570", "K082682", "K040119", "K083039", "K053655", "K051879", "K123356", "K940205", "K111584", "K091142", "K162965", "K020049", "K161221", "K991567", "K011025", "K152206", "K831727", "K150668", "K223052", "K041669", "K852011", "K001738", "K112786", "K160869", "K021160", "K050337", "K040835", "K183472", "K961811", "K101587", "K083898", "K052322", "K033985", "K060829", "K141084", "K844225", "K034039", "K070405", "K141721", "K061030", "K162554", "K973379", "K031332", "K030782", "K214070", "K896946", "K120019", "K073219", "K060984", "K043259", "K923657", "K040621", "K071986", "K080452", "K182255", "K021105", "K070560", "K082176", "K094061", "K203600", "K162388", "K040868", "K851086", "K183398", "K103787", "K172937", "K083823", "K011027", "K142326", "K021107", "K150712", "K844228", "K241126", "K013625", "K983162", "K041140", "K071807", "K213125", "K192452", "K831725", "K134033", "K982330", "K201313", "K040364", "K162461", "K073391", "K081882", "K110402", "K062558", "K120605", "K130547", "K140306", "K040756", "K062320", "K141053", "K243595", "K182493", "K182259", "K070738", "K250598", "K111436", "K133306", "K051048", "K071016", "K053562", "K171817", "K090778", "K021056", "K830889", "K262406", "K915774", "K081538", "K963175", "K170016", "K200311", "K132025", "K042809", "K110581", "K082687", "K071065", "K192615", "K062696", "K922308", "K020455", "K062915", "K980431", "K142070", "K831726", "K173242", "K122048", "K201000", "K894580", "K991296", "K203496" ], "device_name": "Mesh, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2", "registration_number": [ "9615742", "3015413883", "3045042524", "1416980", "3003418325", "3012669262", "3015543569", "3003604053", "2124215", "1047843", "2132242", "1647098", "3013307971", "3012448339", "3009417901", "3000931034", "3010178296", "8043792", "3010894343", "9617465", "3005636544", "3009882464", "3015531529", "1111225", "3010155661", "3018094310", "1220948", "2023811", "3014003617", "3013820501", "9680579", "3010600625", "3012358417", "2530154", "1048735", "1319660", "3016003911", "2183620", "3016823837", "3014461810", "3008868758", "2024024", "1220477", "1018470", "1450662", "3008812560", "3016429246", "3004170064", "3027383505", "1213643", "1526534", "3000215346", "2249852", "1835959", "1221816", "3005920706", "3004464325", "3012547639", "3002807561", "3004681519", "3002924436", "3027448274", "3013666218", "1000393132", "1649390", "8010177", "1820334", "3009039068", "2245304", "2030598", "1818910", "1018233", "1121308", "3002719998", "3012102437", "3010400367", "1550222", "2246552", "3005497913", "3036710971", "2244478", "2183744", "3003300673", "9614442", "3007321028", "3009504230", "3003936139", "3010513348", "3006017180", "3005619880", "3009493875" ], "fei_number": [ "3015413883", "3045042524", "1416980", "3003418325", "1000203464", "3012669262", "3015543569", "3003604053", "2124215", "1047843", "3013307971", "3012448339", "3009417901", "3000931034", "3010894343", "3005636544", "3009882464", "3015531529", "3002821504", "1111225", "1000307073", "3003769549", "3010155661", "3018094310", "1220948", "1000143837", "2023811", "3003110073", "3014003617", "3013820501", "3010600625", "3012358417", "1000136269", "1048735", "3016003911", "2183620", "3016823837", "3014461810", "3008868758", "2024024", "1220477", "1018470", "1000518731", "1450662", "3008812560", "3016429246", "1000136478", "3004170064", "3027383505", "3002808269", "1213643", "1526534", "3000215346", "1000306051", "3005920706", "3004464325", "3012547639", "3002807561", "3003870583", "3002924436", "3027448274", "3013666218", "1000393132", "3003521774", "3000303710", "1820334", "3009039068", "2245304", "1818910", "1018233", "1121308", "3002719998", "3012102437", "3010400367", "3008817245", "1000148471", "3000718467", "1550222", "2246552", "3005497913", "3036710971", "2183744", "3003300673", "3007321028", "3009504230", "3003936139", "3010513348", "3006017180", "3002340648", "3005619880", "3009493875" ] } } ] }