{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "158793", "product_res_number": "Z-0066-2018", "event_date_initiated": "2017-06-26", "event_date_posted": "2017-11-06", "recall_status": "Open, Classified", "res_event_number": "77801", "product_code": "LOD", "k_numbers": [ "K091608" ], "product_description": "Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS\nCobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures", "code_info": "Lot Numbers: 508250, 959680", "firm_fei_number": "1000116912", "recalling_firm": "Encore Medical, Lp", "address_1": "9800 Metric Blvd", "city": "Austin", "state": "TX", "postal_code": "78758-5445", "additional_info_contact": "Neeta Sharma\n512-832-9500", "reason_for_recall": "Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.", "root_cause_description": "Vendor change control", "action": "Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 2017 to all affected customers. The firm initiated their recall to their distributors on 06/26/2017 requesting that they destroy any product on hand. \n\nThe firm then expanded their recall on 09/14/2017, beginning their notification by email and following with letters to hospitals delivered on 09/21 and 09/22/2017. The firm requested the following actions:\n\n\"1. Complete the Acknowledgement/Questionnaire provided with this lot specific field safety notice and return to Stericycle by email to DJO5504@stericycle.com or by fax to 866-608-3939. If you have any questions or issues related to sending this information, please call 877-551-7153.\n2. Quarantine this affected product. Arrangements will be made to finalize the handling of the product as well as coordinate the replacement product where applicable.\n3. If packaging issues are found, please contact DJO Surgical Customer Service to initiate a product complaint.\"\nCustomers with questions were instructed to call 512-834-6255.", "product_quantity": "1815 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K181282", "K150119", "K043403", "K250760", "K041656", "K172408", "K070015", "K001160", "K192379", "K030904", "K030086", "K053003", "K202475", "K033382", "K023012", "K211163", "K170802", "K023103", "K030903", "K193061", "K211869", "K062553", "K010586", "K171540", "K182260", "K123081", "K210120", "K022251", "K050854", "K051496", "K031430", "K014199", "K051532", "K192394", "K210125", "K000943", "K092773", "K021715", "K050085", "K092150", "K254107", "K213812", "K143100", "K993836", "K123225", "K212729", "K150408", "K033563", "K142157", "K143134", "K053198", "K002652", "K033596", "K013755", "K091608", "K231556", "K053445", "K021499", "K202458", "K190766", "K153737", "K081155", "K173494", "K030902", "K210607", "K031673", "K033509", "K050855", "K022688", "K032945", "K193059", "K241674" ], "pma_number": [ "N17755", "N17004", "P970010", "P810020", "N17113", "N17003", "N18466", "P960001" ], "registration_number": [ "8030965", "3008328679", "3010536692", "3021638889", "9615788", "3021566676", "3008110533", "3013176080", "3015516266", "3011683674", "3013186738", "3005941719", "3040335671", "1123169", "1526439", "2249697", "1649518", "3009417901", "3008132398", "3033589330", "9610726", "1000461041", "1818910", "9617616", "3000270450", "3015219237", "2648623", "3013546462", "9614841", "9610921", "3009685086", "3002808022", "2648666", "3005180920", "3008812560", "3010097171", "2031093", "3002806603", "3015225571", "3012502601", "3006406161", "3020163307", "3006524618", "3004638532", "3010898856", "3035366890", "9616671", "3014003062", "2649614", "9681465", "3014302784", "9615014", "8043792", "3012536737", "3010132111", "3015399803", "3004464325", "1825034", "3003678543", "3006849754", "3015967359", "3010537287", "3008868758", "3002907620", "3007663067", "3010162973", "3002807314", "3006950086", "3006946279", "3015542154", "3013055499", "9616662", "9612420", "3017155536", "3016678045", "2953359", "3015309643", "3034676720", "1644408", "3015207155", "1721504" ], "fei_number": [ "3001236277", "3008328679", "3010536692", "3021638889", "1000123143", "3021566676", "3002807111", "3008110533", "3002807305", "3013176080", "3015516266", "3011683674", "3013186738", "3040335671", "1526439", "3009417901", "3033589330", "3000335778", "1000461041", "1818910", "3001236549", "3000270450", "3015219237", "3002807156", "2648623", "3013546462", "3009685086", "3002808022", "2648666", "3005180920", "3008812560", "3010097171", "3002806603", "3015225571", "3002807113", "3012502601", "3003070421", "3002807091", "3006406161", "3020163307", "3000215205", "3004638532", "3010898856", "3035366890", "3005568854", "3014003062", "3002807041", "2649614", "3014302784", "3012536737", "3010132111", "3015399803", "3004464325", "1825034", "3003678543", "3006849754", "3015967359", "3010537287", "3008868758", "3002907620", "3002854251", "3002806724", "3007663067", "3002807314", "3002808269", "3003854593", "3006950086", "3006946279", "3002807172", "3010813691", "3003272754", "3015542154", "3013055499", "1000116912", "3017155536", "3016678045", "3015309643", "3034676720", "3015207155", "3002808402", "1721504" ], "device_name": "Bone Cement", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3027", "device_class": "2" } } ] }