{ "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": "176027", "product_res_number": "Z-0040-2020", "event_date_initiated": "2019-08-21", "event_date_created": "2019-10-04", "recall_status": "Terminated", "event_date_terminated": "2020-09-17", "res_event_number": "83652", "product_code": "FTM", "k_numbers": [ "K140306", "K173242", "K182255" ], "product_description": "CanGaroo Envelopes labeled as the following: \n\n1. CanGaroo Envelope (Large) (single pack); \n\n2. CanGaroo Envelope (Medium) (single pack); \n\n3. CanGaroo Envelope (Extra Large) (single pack); \n\n4. CanGaroo Envelope (Extra Extra Large) (single pack); \n\n5. CanGaroo Envelope (Large) (5 pack); \n \n6. CanGaroo Envelope (Medium) (5 pack); \n\n7. CanGaroo Envelope (Extra Large) (5 pack); \n\n8. CanGaroo Envelope (Extra Extra Large) (5 pack)\n\nProduct Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.", "code_info": "1. Catalog Number CMCV-009-LRG (UDI Number 000859389005065) Lot Numbers: M18B1053, M18D1080, M18D1081, M18D1091, M18D1095, M19B1077, M19C1083, M19D1144, M19D1148;   2. Catalog Number CMCV-009-MED (UDI Number 000859389005034) Lot Numbers: M18C1071, M18D1088;   3. Catalog Number CMCV-009-XLG (UDI Number 000859389005072) Lot Numbers: M18B1051, M18B1052, M18B1054, M18C1068, M18C1069, M19D1160, M19D1163;   4. Catalog Number CMCV-009-XXL (UDI Number 000859389005119) Lot Numbers: M18D1094, M19C1101, M19C1123;   5. Catalog Number CMCV-010-LRG (UDI Number 010859389005062) Lot Numbers: M18A1007, M18M1303, M18N1330, M19B1071, M19C1104, M19C1119;   6. Catalog Number CMCV-010-MED (UDI Number 010859389005031) Lot Number M18A1015;   7. Catalog Number CMCV-010-XLG (UDI Number 010859389005079) Lot Numbers: M18F1160, M18F1161;   8. Catalog Number CMCV-010-XXL (UDI Number 010859389005116) Lot Number M18F1159", "firm_fei_number": "3005619880", "recalling_firm": "AZIYO BIOLOGICS", "address_1": "1100 Old Ellis Rd", "city": "Roswell", "state": "GA", "postal_code": "30076-4992", "additional_info_contact": "877-651-2628", "reason_for_recall": "Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.", "root_cause_description": "Under Investigation by firm", "action": "Aziyo Biologics notified customers on about 08/26/2019 via letter. The letter informed customers of potential suture brittleness or breakage along the envelope seam prior to the expiration of the device. \n\nCustomers were instructed to immediately discontinue use of affected lots and return them to Aziyo for replacement at no cost. Customers are directed to contact Customer Service at 877-651-2628 to initiate the return, using RGA # 19-1994R. Additionally, customers are instructed to acknowledge of receipt of the recall notice by email (customerservice@aziyo.com), fax (678-680-5486), or telephone (877-651-2628), and return of the Acknowledgement and Receipt Form attached to the recall notification. \n\nAn updated consignee letter was sent on about 09/04/2019. The letter contained the same information and instructions but notified customers that this action was a removal and not a market withdrawal.", "product_quantity": "2693 units", "distribution_pattern": "US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.", "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" ] } } ] }