{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "72482", "product_res_number": "Z-0115-2009", "event_date_initiated": "2008-07-02", "event_date_posted": "2008-10-20", "recall_status": "Terminated", "event_date_terminated": "2012-08-17", "res_event_number": "48995", "product_code": "HWA", "product_description": "Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000\nNon Sterile\nHowmedica Osteonics Corp.\n325 Corporate Drive\nMahwah, NJ 07430\nThe Impactor/Extractor is used for insertion and removal of a tibial baseplate during total knee arthroplasty.", "code_info": "All Lot Codes", "firm_fei_number": "3003070421", "recalling_firm": "Stryker Howmedica Osteonics Corp.", "address_1": "325 Corporate Dr", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2002", "additional_info_contact": "Brian McGuire\n201-831-5918", "reason_for_recall": "Stryker Orthopaedics became aware that there is a potential inability to release the Scorpio Series 7000 Tibial Impactor/Extractor from a tibial baseplate during use.", "root_cause_description": "Component design/selection", "action": "US recall notification (product correction) letters were send out by Federal Express with return receipt on July 2 and 9, 2008.\nAdvisory notices were sent to foreign customers on July 2, 2008.\nBoth letters include a Product Correction Bulletin that instructs all used to lubricate the divide with an approved medical lubricant, especially the extractor shaft and threads. It is recommended that all moving parts be evaluated for functionality and useful service prior to each surgery and instructions on how to perform this process. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5918 for assistance.", "product_quantity": "5126", "distribution_pattern": "Worldwide including the US and Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America.", "openfda": { "k_number": [ "K841627", "K864422", "K933527", "K770205" ], "registration_number": [ "", "1038671", "3003120897", "3009973699", "3023449169", "3008544874", "1644408", "3020155054", "3012755988", "3010065126", "9614986", "1833053", "3010141347", "1051526", "3013055499", "3007539489", "1421879", "3007410669", "3018094310", "3008021110", "3012130008", "3015542154", "3031240334", "3009158523", "8044098", "3007420745", "3019356409", "3000931034", "3003639920", "9611278", "3016050940", "3002949614", "3005144609", "1224360", "2027487", "3013912820", "1000517406", "3013875765", "3005528784", "2031009", "9613910", "9613369", "3023265483", "3006721341", "1531174", "3017264244", "3010303097", "8043862", "1526439", "3008285983", "3012447612", 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