{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219397", "product_res_number": "Z-1946-2026", "event_date_initiated": "2026-03-30", "event_date_posted": "2026-04-24", "recall_status": "Open, Classified", "res_event_number": "98665", "product_code": "JDZ", "product_description": "Brand Name: Disposable Mixing Bowls with Spatula\nProduct Name: Mixing Bowl and Spatula\nModel/Catalog Number: 00-5049-011-00\nSoftware Version: N/A\nProduct Description: Mixing Bowl and Spatula\nComponent: N/A", "code_info": "Lot Code: Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301014(10)85390029 ; Individual UDI (01)00889024376564(17)301014(10)85390029 ; Lot Number 85390029 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301103(10)85682882 ; Individual UDI (01)00889024376564(17)301103(10)85682882 ; Lot Number 85682882 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301001(10)85390028 ; Individual UDI (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300422(10)82395239 ; Individual UDI (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300423(10)82395240 ; Individual UDI (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300929(10)85390027 ; Individual UDI (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300924(10)85390026 ; Individual UDI (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300415(10)82395238 ; Individual UDI (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300922(10)85390025 ; Individual UDI (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300826(10)85390022 ; Individual UDI (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300918(10)85390024 ; Individual UDI (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300722(10)85390023 ; Individual UDI (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023 \nModel No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)310122(10)86970970 ; Individual UDI (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "1800 W Center St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2304", "additional_info_contact": "411 Technical Services\n800-6136131", "reason_for_recall": "Ten complaints have been received identifying issues at the time of use related to the package seal,\nincluding incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.", "root_cause_description": "Vendor change control", "action": "On March 30, 2026, the firm began notifying customers via letters titled \"URGENT MEDICAL DEVICE RECALL.\"\n\nRisk Managers were instructed to notify affected personnel and locate and quarantine affected product in inventory. A Zimmer Biomet sales representative may remove and return the affected product on your behalf, or the customer may choose to directly return all affected product from their facility.\n\nSurgeons were informed that there are no specific patient-monitoring instructions recommended beyond existing follow up schedules.", "product_quantity": "66960", "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.", "openfda": { "k_number": [ "K934253", "K854077", "K760636", "K760617", "K792186", "K780857", "K853310", "K843219", "K861086", "K851205", "K892937", "K925025", "K912190" ], "registration_number": [ "3015225571", "3002808022", "3013186738", "3013557562", "3002558847", "3015831087", "3017910185", "1820334", "3005012805", "3012494290", "3006535925", "2649614", "3008788129", "3009475067", "3015542154", "3008388427", "1030489", "3038613790", "3036756245", "3014620201", "2648623", "3004142400", "3009599228", "3024088964", "2086043", "3014326245", "3004638532", "1417485", "3004046477", "9616671", "3005941719", "3006636962", "2648666", "1058584", "3000931034", "9616662", "3010536692", "1020279", "3015967359", "3042205143", "3006950086", "3011683674", "1215305", "3003169405", "3007997036", "3033589330", "1644312", "3002907620", "3009732568", "1822565", "3027234828", "2183301", "3027518990", "9614841", "3003477135", "3010178296", "1526350", "3015309643", "3015219237", "3035366890", "3003542872", "3006552587", "3006406161", "2530154", "1724474", "3005562917", "3010147274", "1721504", "3020163307", "1424263", "3008110533", "1450662", "3033509898", "3038503932", "3015207155", "9613350", "3007699035", "3025603301", "3014683120", "3007255375", "1526534", "3008114965", "3008583793", "1818910", "1423662", "3030733800", "9617616", "1526711", "3009125070", "3043648115", "9617155", "3011210208", "9615788", "3018242561", "3008812560", "9615014", "1928237", "9610921", "3008328679", "3002806603", "9615399", "3012497308", "3033536319", "3011944170", "3002807315", "3010303097", "3012536737", "3005176727", "3030446844", "3008770707", "2437780", "1417592", "3004734264", "3018094310", "3038718579", "3004111573", "8043792", "1649518", "3016678045", "1721676", "3010898856", "3015173212", "3012725451", "1825034", "3009504230", "3006847937", "3030412764", "1526439", "3003120897", "3008132398", "3002807295", "3005180920", "3009170227", "1123169", "3007366790" ], "fei_number": [ "3015225571", "3002808022", "3002808402", "3013186738", "3013557562", "3002558847", "3015831087", "3017910185", "1820334", "3005012805", "3012494290", "3006535925", "2649614", "3008788129", "3009475067", "3015542154", "3008388427", "3038613790", "3036756245", "3014620201", "2648623", "3004142400", "3003272754", "3009599228", "3024088964", "1000123143", "3014326245", "3004638532", "1417485", "3004046477", "3002807111", "3006636962", "2648666", "3000931034", "3010536692", "3005233524", "1020279", "3015967359", "3042205143", "1000307073", "3006950086", "3011683674", "1215305", "3003169405", "3007997036", "3033589330", "3003015552", "1000117748", "3002807091", "3000335778", "3002907620", "3009732568", "3027234828", "2183301", "3002574147", "3027518990", "3003477135", "3003094851", "1526350", "3015309643", "1000220733", "3015219237", "1000477302", "3035366890", "3003542872", "3006552587", "3006406161", "3005562917", "3010147274", "1721504", "3020163307", "3008110533", "1450662", "3033509898", "3038503932", "3003854593", "3015207155", "1000219637", "3007699035", "3025603301", "3014683120", "3007255375", "1526534", "3008114965", "3008583793", "1818910", "3030733800", "1526711", "3002854251", "3009125070", "3000719964", "3043648115", "3011210208", "3001236277", "3018242561", "3008812560", "1928237", "3008328679", "3002806603", "3033536319", "3012497308", "3011944170", "3002807315", "3010303097", "3012536737", "3005176727", "3030446844", "3008770707", "1417592", "3004734264", "3002806724", "3018094310", "3038718579", "3000215273", "3004111573", "3005568854", "1000345108", "3002808269", "3016678045", "1721676", "3010898856", "3015173212", "3012725451", "3001746544", "3009504230", "1825034", "3030412764", "3006847937", "3003110073", "1526439", "3003120897", "3002807295", "3005180920", "3009170227", "3007282753" ], "device_name": "Mixer, Cement, For Clinical Use", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4210", "device_class": "1" } } ] }