{ "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": "204900", "product_res_number": "Z-0700-2024", "event_date_initiated": "2023-11-28", "event_date_posted": "2024-01-10", "recall_status": "Open, Classified", "res_event_number": "93577", "product_code": "PML", "k_numbers": [ "K222789" ], "product_description": "VADER pedicle system, torque wrench, Catalog Number 42-702", "code_info": "19/01-001, 19/01-013, 19/01-014, 19/01-015, 190830-10, 190830-23, 190830-42, 190830-44, 190830-45, 190830-50, 190830-51, 190830-52, 200131-54, 200131-56, 200131-62, 200131-64, 200131-68, 200131-69, 200131-70, 200131-72, 200131-73, 200131-74, 200221-040R1, 200424-01, 200424-03, 200424-04, 200424-05, 200424-06, 200424-10, 200424-11, 200424-12, 200424-13, 200424-14, 200424-15, 200424-16, 200424-17, 200424-20, 200424-21, 200424-22,\n200424-24, 200424-25, 200424-27, 200424-29, 200424-32, 200424-34, 200424-35, 200605-051R1, 200605-052R1, 201002-073R1, 210915-005, 210915-009, 210915-010, 210915-011, 210915-012, 220610-001, 220610-003, 220610-008, 220610-019, 220610-020, 220610-021, 220610-025, 220610-026, 220610-030, 230113-003, 230113-005, 230113-007, 230113-008, 230113-009, 230113-010, 230113-011, 230113-012, 230113-013, 230113-014, 230224-029, 230224-034, 230426-038, 230426-039, 230426-042, 230426-043", "firm_fei_number": "3006493760", "recalling_firm": "Icotec Ag", "address_1": "Industriestrasse 12 12 industriestrasse", "city": "Altstatten Sg", "country": "Switzerland", "reason_for_recall": "icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.", "root_cause_description": "Other", "action": "icotec ag issued an URGENT Medical Device Recall notice to its consignees beginning on 11/28/2023 via email. The notice explained the problem with the device, the risk to health, and informed the medical facility that the affected product had been removed prior to the notice. Decision on whether patient-level follow-up is required should be made by the physician.\nReplacements will be provided where applicable. \n\nThe firm expanded this recall on 12/27/2023 (notices delivered by US mail) to include additional lots and one additional product.\n\nContact for questions: Laura Husken, laura.huesken@icotec.ch, Tel.: +41 78 438 78 73", "product_quantity": "79 devices (US only)", "distribution_pattern": "US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA", "openfda": { "k_number": [ "K180498", "K192818", "K221926", "K212489", "K260286", "K222789", "K160879", "K252885", "K172269", "K201362", "K222256", "K241034", "K152604", "K200596", "K230774", "K191148", "K231809", "K171938", "K190526" ], "registration_number": [ "9617616", "2029275", "3003120897", "3010041430", "3030412764", "3007014520", "3009973505", "9615014", "3015869493", "3005739886", "3008114965", "2031966", "1833920", "3009959868", "3019878714", "2648623", "8043792", "1835251", "3007993775", "3015941638", "3017155536", "9610726", "3018094310", "3004142400", "3006493760", "9681465", "3010047454", "3007728266", "3037407500", "3005823819", "3014725904", "1649518", "3008868758", "3006791286", "1224360", "3010120104", "3040335671", "1030489", "3006128100", "3003935342", "1526534", "1226544", "3019767615", "3016438694", "3023852420", "3010363503", "1834331", "2027467", "3008132398", "3010049501", "1424263", "3013546462", "3010032903", "1221763", "3009050824", "3005180920", "3003761012", "2647346", "9614841", "1824199", "3015831087", "3006849754", "2648666", "9611390", "3014003062", "3006783837", "3005497913", "3008110533", "3006639944", "3007441485", "9612277", "3015967359", "9615128", "3002806603", "3010120326", "1056553", "1526439", "3043543260", "3006017180", "3009144915", "3005677016", "3015219237" ], "fei_number": [ "3003128516", "1000514086", "3003120897", "3010041430", "3030412764", "3007014520", "3009973505", "3011764740", "3015869493", "3002808402", "3005739886", "3008114965", "3009959868", "3019878714", "2648623", "1000306340", "3000205591", "3007993775", "3002807172", "3017155536", "3001236277", "3018094310", "3004142400", "1000306431", "3006493760", "1000477302", "1000115656", "3010047454", "3007728266", "3037407500", "3014725904", "3008868758", "3002807328", "3006791286", "3010120104", "3040335671", "3008820440", "3006128100", "3003935342", "3002808269", "1526534", "3002806773", "3019767615", "3016438694", "3023852420", "3010363503", "3003272754", "2027467", "1000132370", "3010049501", "3002807091", "3005568854", "3013546462", "3010032903", "1221763", "3009050824", "3005180920", "3003761012", "2647346", "3002980729", "1824199", "3015831087", "3006849754", "3005532635", "2648666", "3014003062", "3005497913", "3008110533", "3006639944", "3007441485", "3003015552", "3002807113", "3015967359", "3002806603", "3010120326", "1526439", "3043543260", "3006017180", "3009144915", "3009322142", "3005677016", "3015219237" ], "device_name": "Bone Cement, Posterior Screw Augmentation", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3027", "device_class": "2" } } ] }