{ "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": "178364", "product_res_number": "Z-0781-2020", "event_date_initiated": "2019-11-21", "event_date_created": "2020-01-07", "recall_status": "Terminated", "event_date_terminated": "2020-11-13", "res_event_number": "84451", "product_code": "JEC", "k_numbers": [ "K102885" ], "product_description": "Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm\nCatalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures", "code_info": "Lot Number: D30875 UDI : (01)07613327089158(10)D30875", "firm_fei_number": "3002807830", "recalling_firm": "Stryker GmbH", "address_1": "Bohnackerweg 1 1 bohnackerweg", "city": "Selzach", "country": "Switzerland", "reason_for_recall": "Pin To Rod Coupling could not clamp the pin and rod as intended", "root_cause_description": "Under Investigation by firm", "action": "Stryker issued Urgent Medical Device Recall - PFA 2227937 letter on November 21, 2019 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter was also issued at the country level. The letter states reason for recall, health risk and action to take: Actions Needed:\n1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.\n2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore.\n3.Quarantine and discontinue use of the recalled devices.\n4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-844-782-5565 or email to Strykerortho2917@stericycle.com\n5.Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address.\nStryker Orthopaedics/PFA Product Returns PFA 2227937\nAttn: Distribution Inventory Team\n325 Corporate Drive\nDock M-East\nMahwah, NJ 07431", "distribution_pattern": "Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.", "openfda": { "k_number": [ "K071476", "K842343", "K013818", "K770388", "K802722", "K800184", "K901984", "K934698", "K790262", "K991732", "K884798", "K022676", "K894098", "K802776", "K961618", "K822780", "K981423", "K781839", "K965029", "K192465", "K203605", "K894959", "K952730", "K833114", "K872538", "K894982", "K881673", "K961916", "K840856", "K842493", "K193256", "K802814", "K003848", "K963614", "K761088", "K831576", "K830154", "K931578", "K802723", "K102885", "K163028", "K012193", "K915800", "K022065", "K781840", "K960782", "K181192", "K072432", "K770066", "K881896", "K936045", "K781841", "K892638", "K944092", "K030519", "K993099", "K930153", "K132731", "K841334", "K803166", "K954667", "K781793", "K933968", "K884242", "K984442", "K922796", "K903105", "K880282", "K171863", "K082679", "K920149", "K852397", "K032427", "K031941", "K882877", "K936124", "K952330", "K971755", "K920117", "K042066", "K791466", "K954838", "K943857", "K792561", "K914858" ], "registration_number": [ "3009350690", "1043534", "3010860227", "1720929", "3011683674", "2028632", "1043653", "3033509898", "1054811", "1526534", "2029275", "3015882686", "1828288", "3013004243", "3004464325", "3032391", "3035366890", "3000270450", "2032098", "3010287687", "3013055499", "1057946", "9680825", "3013176080", "2531232", "3006694268", "3036756245", "1825034", "3008114965", "1526439", "3015207155", "9610905", "2919128", "3023852420", "8031020", "1047843", "3015542154", "3008812560", "3006946279", "3034676720", "2183449", "3010667733", "3006015326", "3025141", "2031910", "2032112", "1828464", "2090040", "3005061536", "3009417901", "3005893246", "3011500362", "3008868758", "2011171", "3003860203", "1423662", "1220246", "1834379", "3025603301", "1818910", "1066368", "3008534770" ], "fei_number": [ "3009350690", "1043534", "3010860227", "1720929", "3011683674", "1043653", "3002615969", "3033509898", "1526534", "3015882686", "3002299608", "1828288", "3013004243", "3002807464", "3004464325", "3035366890", "3000270450", "3003058448", "3010287687", "3013055499", "3003346235", "3013176080", "1000306431", "3006694268", "3036756245", "1825034", "3002926812", "3000215273", "3008114965", "1526439", "3003076831", "3015207155", "2919128", "3002807830", "3023852420", "1047843", "3015542154", "3008812560", "3006946279", "3034676720", "2183449", "3010667733", "1000114185", "1000125930", "3000215566", "3006015326", "1828464", "1000306303", "3005061536", "3002807827", "3009417901", "3005893246", "3011500362", "3008868758", "2011171", "3003860203", "1220246", "1818910", "3025603301", "1000125025", "1000525271", "3008534770" ], "device_name": "Component, Traction, Invasive", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3040", "device_class": "2" } } ] }