{ "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": "169577", "product_res_number": "Z-0709-2019", "event_date_initiated": "2018-11-20", "event_date_created": "2019-01-10", "recall_status": "Terminated", "event_date_terminated": "2020-04-14", "res_event_number": "81704", "product_code": "LXT", "k_numbers": [ "K112345" ], "product_description": "Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile\nITEM 131827118 \n\nProduct Usage: Usage:\nThe system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone", "code_info": "LOT 029970 UDI (01)00880304535572(17)280501(10)029970", "firm_fei_number": "1825034", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "additional_info_contact": "411 Technical Services\n574-371-3071", "reason_for_recall": "One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws", "root_cause_description": "Packaging process control", "action": "Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.", "product_quantity": "50 pieces", "distribution_pattern": "Country of Japan", "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" ] } } ] }