{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161205", "product_res_number": "Z-0814-2018", "event_date_initiated": "2017-09-12", "event_date_created": "2018-03-01", "recall_status": "Terminated", "event_date_terminated": "2021-01-19", "res_event_number": "79019", "product_code": "ISY", "product_description": "OTTO BOCK Kenevo knee joints Model 3C60", "code_info": "Serial Numbers:  201520007, 201520010, 201520012, 201520008, 201520009, 201522040, 201520002, 201520011, 201520006, 201522046, 201522043, 201520028, 201528134, 201528139, 201520013, 201522045, 201525069, 201525109, 201524051, 201524050, 201549087, 201550012, 201550020, 201550022, 201550017, 201550028, 201550027, 201550016, 201550036, 201550014, 201551005, 201550025, 201551028, 201551030, 201550040, 201551032, 201602031, 201602030, 201603014, 201603016, 201603023, 201602034, 201602036, 201602032, 201551034, 201603029, 201603027, 201603028, 201610008, 201601018, 201610010, 201610015, 201610019, 201610022, 201610020, 201611001, 201611010, 201520027, 201610030, 201610035, 201611012, 201603025, 201611002, 201611018, 201612018, 201612020, 201613021, 201613019, 201615008, 201618017, 201616010, 201613008, 201616004, 201616005, 201616012, 201618023, 201618021, 201618018, 201618019, 201618024, 201617031, and 201618025.", "firm_fei_number": "3005190268", "recalling_firm": "Otto Bock Healthcare Product", "address_1": "Brehmstrase 16 16 brehmstrase", "city": "Vienna", "country": "Austria", "additional_info_contact": "Customer Service\n800-328-3458", "reason_for_recall": "Otto Bock Healthcare Products GmbH has identified a design issue through extended durability\ntesting where the pylon clamping mechanism has the potential to cause damage to the\npylon. When used longer than 1.45 million cycles (which represents approximately 2.3\nyears of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened\naccording to the labeled torque specification, AND the patient weighs at most\n125kg it may be remote that the pylon breaks, and causing the patient to fall.\nThere have been no failures or complaints reported directly attributed to the failure mode\ncollapsed pylon.\n\nIn the US Market and in Canada, labeling requires a condition based service at three years.\n\nIn the rest of the world, a mandatory two year service interval is specified. Only the devices\nin distribution in the United States and Canada are affected by this action.", "root_cause_description": "Device Design", "action": "On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service.\nCustomer Service: (800) 328-3458 Option 1\nLoaner Service: (800) 328-3458 Option 3, then Option 1", "product_quantity": "75 units", "distribution_pattern": "AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA\nAU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU", "openfda": { "registration_number": [ "1058311", "3011287176", "3042765984", "3004161950", "1000357070", "1000228440", "2531695", "1022826", "3026131691", "9680835", "3005190268", "3004134478", "3013164247", "3007048017", "3022549", "1522166", "1043533", "9616086", "3010220187", "3006899173", "3030413824", "1026765", "3014847663", "3009340798", "3017264244", "3036017026", "3043049054", "3013002868", "3026078097", "3022320321", "3005885000", "3013742611", "9616494", "3012035815", "3004737223", "3017274509", "1000328618", "3018070833", "1058063", "2242474", "3005347856", "3030088168", "2950684", "3005846457", "3005748172", "3008523132", "3013657868", "3005245962", "3028013069", "9710137", "3042227943", "1834241", "3031606416", "3008584163", "3003764610", "3027645766", "3004646509", "3006975749", "3005694504", "8010401", "3029890418", "3030541652", "1926174", "1000431265", "9617046" ], "fei_number": [ "3011287176", "3042765984", "3004161950", "1000357070", "3003050402", "1000228440", "5812", "3026131691", "1022826", "3006076154", "3005190268", "3004134478", "3013164247", "3007048017", "3022549", "1522166", "3010220187", "3006899173", "3003590404", "3030413824", "1026765", "3014847663", "3009340798", "3002687265", "3017264244", "3036017026", "1000222138", "3043049054", "3003117657", "1000123590", "3003050720", "1000220701", "3013002868", "3026078097", "3022320321", "3005885000", "3013742611", "3012035815", "3004737223", "3017274509", "1000328618", "1000307649", "3018070833", "2242474", "3005347856", "3030088168", "3005846457", "3005748172", "3008523132", "3013657868", "3005245962", "3028013069", "3042227943", "1000222175", "3031606416", "3008584163", "3003764610", "3027645766", "3004646509", "3006975749", "3005694504", "3029890418", "3030541652", "1926174", "1000431265" ], "device_name": "Joint, Knee, External Limb Component", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3420", "device_class": "1", "k_number": [ "K101859" ] } } ] }