{ "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": "143158", "product_res_number": "Z-0788-2016", "event_date_initiated": "2016-01-21", "event_date_posted": "2016-02-09", "recall_status": "Terminated", "event_date_terminated": "2017-05-31", "res_event_number": "73141", "product_code": "LYC", "k_numbers": [ "K110449" ], "product_description": "Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures.\nEndobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: \" Alveolar ridge augmentation/reconstruction, \" Sinus elevation, \" Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, \" Filling of bone defects after apicectomy, \" Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.", "code_info": "Item Numbers &Lot 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"firm_fei_number": "3006946279", "recalling_firm": "Biomet France SARL", "address_1": "Plateau de Lautagne Valence Cedex", "postal_code": "9", "country": "France", "additional_info_contact": "Kevin W. Escapule\n574-372-4487", "reason_for_recall": "Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.", "root_cause_description": "Under Investigation by firm", "action": "Zimmer BIOMET France SARL has initiated a voluntary recall via certified mail on January 2, /2016 for the Endobon Xenograft Granules, based on limited (in vitro/bench) results which indicated cytotoxicity tests were not passed at 36 months (real-time) aging. Use of the Endobon Xenograft Granules may result in patient may experiencing soft tissue irritation, up to and including infection. \nCustomers area asked to do the following: 1. Please review this notice.\n2. Identify, remove from service and segregate all affected Endobon ROX* product in your inventory.\n3. Complete the attached Business Reply Form (Attachment 1) and:\na. Fax it to 877-650-0368 or email it to Biomet5351@stericycle.com.\n4. If you have product to return, contact BIOMET 3i at the number on the Business Reply Form for an RMA number and return shipping label.\na. Return a copy of the Business Reply Form along with any affected product to the address on the Business Reply Form.\nReplacement product will immediately ship based upon availability.\nFor assistance or other questions that customers may have relative to this notice, please contact BIOMET 3i at 1-800-443-8166 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.", "product_quantity": "145,116 units", "distribution_pattern": "Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.", "openfda": { "k_number": [ "K981182", "K020720", "K033098", "K081784", "K051885", "K011403", "K843154", "K082917", "K832509", "K821752", "K902295", "K873763", "K110198", "K791416", "K013346", "K112428", "K813070", "K010701", "K051381", "K962548", "K072058", "K053374", "K850012", "K862061", "K943186", "K885067", "K014289", "K253317", "K101014", "K111087", "K081561", "K910432", "K213260", "K955096", "K031813", "K993784", "K093122", "K023799", "K051091", "K863237", "K843153", "K083005", "K852766", "K140374", "K102015", "K010775", "K072052", "K030052", "K090083", "K093390", "K934430", "K993610", "K033110", "K071817", "K852682", "K941780", "K882098", "K131385", "K934947", "K852742", "K830304", "K843398", "K042706", "K052493", "K900136", "K950511", "K952619", "K940643", "K101718", "K921468", "K924287", "K101426", "K092788", "K994137", "K062102", "K202675", "K992416", "K070784", "K081721", "K950598", "K093871", "K003286", "K980679", "K970569", "K932866", "K083742", "K003457", "K121177", "K924286", "K102208", "K942946", "K962786", "K092567", "K153230", "K111105", "K051443", "K000633", "K090950", "K020396", "K251818", "K960267", "K862324", "K001598", "K842163", "K960348", "K040646", "K192597", "K960164", "K950306", "K050260", "K031073", "K072056", "K092194", "K970321", "K091618", "K983104", "K841201", "K891173", "K920508", "K973594", "K101827", "K954631", "K842718", "K860983", "K153676", "K954763", "K102812", "K122240", "K062834", "K092087", "K950165", "K053387", "K023998", "K952922", "K080308", "K083372", "K091729", "K970884", "K934049", "K930115", "K030195", "K063596", "K040783", "K070055", "K990537", "K100671", "K852199", "K993238", "K091484", "K861083", "K063010", "K942212", "K060285", "K083858", "K072057", "K962838", "K241186", "K112716", "K063549", "K000149", "K090850", "K103820", "K012144", "K952618", "K922487", "K090793", "K063634", "K972842", "K810382", "K243745", "K050170", "K113282", "K201051", "K960361", "K962624", "K972278", "K244006", "K012047", "K011032", "K033729", "K861084", "K003494", "K863176", "K871773", "K924408", "K974399", "K852765", "K201546", "K952617", "K992216", "K080772", "K982699", "K861041", "K960353", "K840260", "K960368", "K042730", "K950567", "K082383", "K060732", "K053022", "K073571", "K081432", "K964342", "K033994", "K880371", "K040278", "K253883", "K811101", "K100883", "K933688", "K072397", "K030682", "K820023", "K923310", "K041324", "K042583", "K103709", "K921469", "K050984", "K981214", "K972817", "K003493", "K962494", "K921776", "K924288", "K010320", "K113049", "K102872", "K110449", "K082286" ], "registration_number": [ "1223843", "9610921", "3004847139", "3004464325", "1220477", "2648988", "2032098", "2530154", "2650143", "3013055499", "3004024955", "3010162973", "1410097", "3011276344", "3007490610", "3003418325", "3021666765", "2011171", "3021912300", "1423662", "3003790304", "3007708799", "3004431266", "2245304", "1319660", "9681465", "1450662", "1928237", "3002807310", "2024024", "3006946279", "1647149", "8030965", "3004203816", "1121308", "3006223010", "1221541", "3009417901", "3011050570", "3004450973", "1650372", "2249852", "3007663067", "3006017180", "3018094310", "1416980", "3006540014", "2029275", "2032542", "3011795235", "3027448274", "3015219237", "3008114965", "3007225376", "3012447612", "9612300", "3010160527", "3008910197", "3002807314", "1066741", "1319639", "3004681519", "3004142400", "3003768919", "3038718579", "9615788", "3002673655", "8043792", "3011824442", "9612827", "1000194445", "3004525100", "3002807315", "2024311", "1030489", "1225112", "3017036472", "1526439", "3003775072", "9610964", "9710629", "9681254", "3015780293", "3008812560", "2219920", "1058584", "9613348", "2431866", "3011936113", "1037007", "3011649314", "2081055", "3003771570", "3002983930", "3016050940", "3005138409", "3003300673" ], "fei_number": [ "3004847139", "3004464325", "1220477", "3013055499", "3002807305", "3004024955", "1000306431", "3004975279", "1410097", "1000477302", "3011276344", "3007490610", "3002807041", "3002808269", "3003418325", "3002806508", "3021666765", "3003646540", "2011171", "3021912300", "3003790304", "3007708799", "3004431266", "2245304", "1000136478", "1450662", "1928237", "1000138054", "3000215273", "3002807113", "3002807310", "2024024", "3006946279", "3002808289", "3000204775", "3004203816", "1121308", "3006223010", "1000219637", "1221541", "3009417901", "3011050570", "3004450973", "3008817245", "1000477999", "3007663067", "1000306139", "3006017180", "3018094310", "1416980", "3006540014", "3003854593", "1000305589", "3011795235", "3027448274", "3015219237", "3008114965", "3007225376", "3012447612", "1000307073", "3003005156", "3008910197", "3002807314", "3002806724", "3004142400", "3003768919", "3038718579", "3002673655", "3011824442", "1000194445", "3004525100", "3005907356", "3002807315", "2024311", "3003058448", "3003870583", "3017036472", "1526439", "3003775072", "3002807040", "3015780293", "3008812560", "2219920", "2431866", "3011936113", "3000206397", "1037007", "3011649314", "2081055", "3003771570", "3002983930", "2648209", "3016050940", "3002253367", "3005138409", "3003407235", "3003300673" ], "device_name": "Bone Grafting Material, Synthetic", "medical_specialty_description": "Dental", "regulation_number": "872.3930", "device_class": "2" } } ] }