{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194709", "product_res_number": "Z-1478-2022", "event_date_initiated": "2022-06-24", "event_date_created": "2022-07-28", "recall_status": "Open, Classified", "res_event_number": "90535", "product_code": "HBE", "k_numbers": [ "K143320" ], "product_description": "Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.", "code_info": "UDI-DI (GTIN): 07613327294910\nAffected Lots: \n22011017\n21330017\n20216017\n20140017\n20139027", "firm_fei_number": "3015967359", "recalling_firm": "Stryker Instruments", "address_1": "1941 Stryker Way", "city": "Portage", "state": "MI", "postal_code": "49002", "additional_info_contact": "Jordan Anderson\n269-800-1347", "reason_for_recall": "There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.", "root_cause_description": "Process change control", "action": "On June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters.\n\nCustomers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product.", "product_quantity": "543", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Arizona, California, \nFlorida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, \nVirginia and the countries of Canada, Netherlands, and Thailand.", "openfda": { "k_number": [ "K251433", "K113476", "K230619", "K930229", "K172709", "K032303", "K984035", "K191049", "K070876", "K170442", "K121264", "K162542", "K153519", "K213072", "K880601", "K062842", "K111520", "K030172", "K253627", "K143399", "K130755", "K213208", "K210377", "K050628", "K161704", "K190172", "K191479", "K250815", "K903664", "K911812", "K002903", "K900388", "K250374", "K014060", "K223199", "K902703", "K232684", "K143320", "K213454", "K072315", "K182436", "K080802", "K132436", "K022942", "K252060", "K873692", "K183545", "K183203", "K935861", "K943541", "K123270", 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