{ "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": "66393", "product_res_number": "Z-0674-2008", "event_date_initiated": "2007-09-28", "event_date_posted": "2008-02-26", "recall_status": "Terminated", "event_date_terminated": "2008-03-20", "res_event_number": "45878", "product_code": "LXT", "k_numbers": [ "K941048" ], "product_description": "Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.", "code_info": "Lot numbers:  For Catalog #50-1101 (75mm): 075; For Catalog #50-1014 (100mm): 7241, 076 and 50826; For Catalog #50-1015 (150mm): 2664-01, 7343 and 080; For Catalog #50-1016 (200mm): 145, 7342 and 068.", "firm_fei_number": "2183449", "recalling_firm": "Orthofix, Inc", "address_1": "1720 Bray Central Dr", "city": "Mckinney", "state": "TX", "postal_code": "75069-8207", "additional_info_contact": "469-742-2500", "reason_for_recall": "Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.", "root_cause_description": "Process control", "action": "Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.", "product_quantity": "69 units.", "distribution_pattern": "Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.", "openfda": { "k_number": [ "K960269", "K001760", "K001084", "K963432", "K962846", "K011948", "K073135", "K033805", "K131636", "K020905", "K874377", "K031973", "K974245", "K001793", "K052754", "K991407", "K090374", "K000972", "K990848", "K051306", "K022651", "K050932", "K050631", "K033145", "K954053", "K060403", "K042059", "K941048", "K000957", "K991723", "K950384", "K003211", "K013739", "K984357", "K030390", "K864403", "K003205", "K132704", "K013772", "K031959", "K002923", "K032169", "K955388", "K051728", "K032705", "K060864", "K953397", "K003240", "K042458", "K963618", "K112345", "K060290", "K991889", "K230067", "K031428", "K000558", "K063832" ], "device_name": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2", "registration_number": [ "1020279", "2437731", "3004049923", "3004983210", "2029275", "1828288", "3003525643", "3013055499", "1644408", "3009417901", "3015542154", "3015440604", "1828464", "1833920", "1825034", "1835572", "3015882686", "8043792", "3007923096", "3014315560", "9680825", "2031910", "3003108161", "3007993775", "3015869492", "1643264", "3006015326", "3007738812", "3004142400", "3006742481", "3015876273", "3010287687", "3014680795", "1043653", "3010158639", "3008868758", "3004748528", "3014302784", "1220477", "3005061536", "3008534770", "1450662", "1000517406", "3010120104", "3006946279", "3005641619", "3008812560", "1835831", "3003387384", "2183449", "3009546990", "1526534", "1054811", "3019767615", "3004976965", "3038503932", "1222773", "2183946", "1834331", "3002907620", "3032391", "3011683674", "3006801265", "3010049501", "3004464325", "3014315669", "1424263", "3003860203", "3033509898", "3000270450", "3021008900", "3007366790", "2245304", "3043355196", "3007539489", "3006694268", "3015399803", "2032098", "2134947", "8031020", "9615800", "3006783837", "3005497913", "3036756245", "2183744", "3025603301", "3013176080", "3010462278", "3014937101", "3034676720", "3035366890", "9611863", "3010120326", "3015212339", "3010162973", "1526439", "3015869121", "3015207155", "3025141", "3005893246" ], "fei_number": [ "1020279", "1000116116", "3004049923", "3004983210", "1000125930", "3001452082", "1000120768", "1828288", "3003525643", "3013055499", "3002807648", "3009417901", "3015542154", "3015440604", "1828464", "1825034", "3015882686", "3007923096", "3014315560", "3001617730", "3003108161", "1000306340", "3007993775", "3002807041", "1643264", "3015869492", "3007282753", "3006015326", "3007738812", "3004142400", "3006742481", "3015876273", "3010287687", "3014680795", "1000306431", "1043653", "1000115656", "3002807830", "3010158639", "3008868758", "3002807827", "3004748528", "3014302784", "1220477", "3005061536", "3008534770", "1450662", "1000517406", "3003058448", "3010120104", "3006946279", "3005641619", "3008812560", "3003387384", "2183449", "3002926812", "3009546990", "3002808269", "1000116912", "1526534", "3019767615", "3004976965", "3038503932", "1000114185", "3002907620", "3001814066", "3011683674", "3006801265", "3010049501", "3004464325", "3014315669", "3010938185", "3003860203", "3033509898", "3000270450", "3021008900", "2245304", "3043355196", "3007539489", "3006694268", "3015399803", "3003051987", "3002299608", "3005497913", "3036756245", "3003015552", "2183744", "3025603301", "3013176080", "3010462278", "3014937101", "3034676720", "3035366890", "3010120326", "3015212339", "1526439", "3015869121", "3015207155", "3009322142", "3005893246" ] } } ] }