{ "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": "122400", "product_res_number": "Z-0280-2014", "event_date_initiated": "2013-11-01", "event_date_posted": "2013-11-14", "recall_status": "Terminated", "event_date_terminated": "2014-02-10", "res_event_number": "66444", "product_code": "JDZ", "product_description": "Acetabular Pressurizer; single use and six units per box.\n\nThe Acetabular Pressurizer 0206-522-000 is an accessory to the\nAdvanced Cement Mixer (ACM). The Acetabular Pressurizer\nTiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000.\n\nThis Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.", "code_info": "Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E Milham Ave", "city": "Portage", "state": "MI", "postal_code": "49002-9704", "additional_info_contact": "269-323-7700", "reason_for_recall": "On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun, a cracked tiplet may release from the Hub during cement applica", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, Stryker Instruments, sent an \"URGENT MEDICAL DEVICE RECALL NOTIFICATION\" letter dated 11/01/2013, to all domestic consignees/customers and an email was sent to the International Subsidiaries and Sales Representatives. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:\n\n1. Immediately review this Recall Notification\n2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found.\n3. Complete the enclosed Business Reply Form to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the Business Reply Form even if you\ndon't have any affected product on hand.\nNote: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification.\n4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF.\n5. Fax the completed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762.\n6. Upon receipt of the Business Reply Form, if you have recalled product on hand, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Acetabular Pressurizers to Stryker.\n7. Upon receipt of recalled Acetabular Pressurizers, credit will be applied to your account.\n\nFor questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2921 or email: kellyjo.whipple@stryker.com.", "product_quantity": "87 boxes (522 each)", "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.", "openfda": { "k_number": [ "K851205", "K861086", "K854077", "K912190", "K780857", "K925025", "K892937", "K843219", "K792186", "K934253", "K760617", "K760636", "K853310" ], "registration_number": [ "1644312", "3003542872", "3006535925", "1526534", "3005012805", "3018094310", "3008328679", "3002807315", "3010536692", "3014620201", "3003120897", "3003477135", "3006552587", "3006636962", "3015173212", "3009732568", "9613350", "1822565", "9615788", "2183301", "3008110533", "3038718579", "2530154", "3010303097", "3011683674", "3013186738", "3005941719", "3007366790", "1123169", "1526439", "3004046477", "1721676", "1649518", "3027234828", "3008132398", "1424263", "3033589330", "3007997036", "1215305", "1818910", "3008770707", "9617616", "3004111573", "3033536319", "3038503932", "3036756245", "3012497308", "3008583793", "3015219237", "3010147274", "3008788129", "2648623", "9614841", "3009125070", "9610921", "3002808022", "3008388427", "3008812560", "3013557562", "2648666", "3005180920", "9615399", "1058584", "3011210208", "3014683120", "3015831087", "3025603301", "3002806603", "3033509898", "1820334", "3015225571", "3030446844", "3027518990", "3006406161", "2086043", "3018242561", "3020163307", "2437780", "3004638532", "1417592", "3042205143", "3010898856", "3003169405", "3035366890", "1928237", "9616671", "3002807295", "2649614", "3008114965", "9615014", "8043792", "3012536737", "1417485", "3010178296", "3038613790", "1825034", "3004734264", "3005176727", "3015967359", "1020279", "3043648115", "1526711", "3012494290", "3011944170", "3002558847", "3002907620", "1724474", "3006950086", "3030412764", "3006847937", "3009599228", "3030733800", "3017910185", "3014326245", "3015542154", "3004142400", "3012725451", "3007699035", "1423662", "3007255375", "1030489", "9616662", "9617155", "3009504230", "3016678045", "1450662", "3015309643", "3024088964", "3015207155", "3005562917", "3009475067", "3000931034", "3009170227", "1721504", "1526350" ], "fei_number": [ "3003542872", "3006535925", "1526534", "3001236277", "3005012805", "3018094310", "3008328679", "3002807315", "3010536692", "3014620201", "3003120897", "1000117748", "3000719964", "1000123143", "3003477135", "3006552587", "3006636962", "3003094851", "3015173212", "3009732568", "3000215273", "2183301", "3002574147", "3002807111", "3008110533", "3038718579", "3010303097", "3011683674", "3013186738", "1526439", "3004046477", "1721676", "1000220733", "3027234828", "3033589330", "3000335778", "3007997036", "1000219637", "1215305", "1818910", "3008770707", "3004111573", "3033536319", "3038503932", "3036756245", "3012497308", "3008583793", "3001746544", "3015219237", "3010147274", "3008788129", "2648623", "1000307073", "3009125070", "3002808022", "3008388427", "3008812560", "3013557562", "2648666", "3005180920", "3011210208", "3003015552", "3014683120", "3015831087", "3025603301", "3002806603", "3033509898", "1820334", "3015225571", "3030446844", "3027518990", "3002807091", "3006406161", "3018242561", "3020163307", "3007282753", "3004638532", "1417592", "3042205143", "3010898856", "3003169405", "3035366890", "3005568854", "1928237", "3002807295", "2649614", "3008114965", "3012536737", "1417485", "3038613790", "1825034", "3004734264", "3003110073", "3005176727", "1000345108", "3015967359", "1020279", "3043648115", "1526711", "3012494290", "3011944170", "3002558847", "3002907620", "3002854251", "3002806724", "3002808269", "3005233524", "1000477302", "3003854593", "3006950086", "3030412764", "3003272754", "3009599228", "3030733800", "3006847937", "3017910185", "3014326245", "3015542154", "3004142400", "3012725451", "3007699035", "3007255375", "3009504230", "3016678045", "1450662", "3015309643", "3024088964", "3015207155", "3005562917", "3009475067", "3000931034", "3009170227", "3002808402", "1721504", "1526350" ], "device_name": "Mixer, Cement, For Clinical Use", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4210", "device_class": "1" } } ] }