{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "66306", "product_res_number": "Z-0623-2008", "event_date_initiated": "2007-10-26", "event_date_posted": "2008-03-20", "recall_status": "Terminated", "event_date_terminated": "2010-01-27", "res_event_number": "45854", "product_code": "KWL", "k_numbers": [ "K800207" ], "product_description": "Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430", "code_info": "Ref No: Description: Lot Code:  UH1-44-28\tUHR BIPOLAR 28X44mm\t3K4MMD UH1-44-28\tUHR BIPOLAR 28X44mm\t5P0MLA UH1-44-28\tUHR BIPOLAR 28X44mm\tJEMMNA UH1-44-28\t04YMPD UH1-44-28\t0YHMMD UH1-44-28\t247MMD UH1-44-28\t29EMPD UH1-44-28\t2HYMRA UH1-44-28\t66NMKD UH1-44-28\t6W5MPD UH1-44-28\t6W6MPD UH1-44-28\t8XEMPD UH1-44-28\t8XKMPD UH1-44-28\t9W0MJA UH1-44-28\tD05MKD UH1-44-28\tED8MND UH1-44-28\tEP2MPA UH1-44-28\tK57MND UH1-44-28\tK6LMND UH1-44-28\tLA6MPA UH1-44-28\tV13MLD UH1-44-28\tV17MLD", "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": "Rita Intorella\n201-831-5825", "reason_for_recall": "Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.", "root_cause_description": "Process control", "action": "Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.", "product_quantity": "360 total", "distribution_pattern": "Worldwide Distribution - USA, Canada, \nChina, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.", "openfda": { "k_number": [ "K062408", "K062273", "K904119", "K905349", "K920231", "K924379", "K896105", "K965198", "K831420", "K800207", "K903877", "K173967", "K973614", "K855228", "K820755", "K821343", "K260536", "K014226", "K954077", "K101356", "K974807", "K984028", "K872535", "K990309", "K842465", "K924050", "K042973", "K844486", "K063791", "K981451", "K922146", "K926120", "K960538", "K950563", "K903884", "K872025", "K833599", "K803191", "K822321", "K252326", "K951355", "K903885", "K031841", "K844818", "K030972", "K262290", "K842234", "K842559", "K852584", "K943778", "K940190", "K811416", "K143184", "K903240", "K191981", "K872776", "K811738", "K864085", "K965156", "K905334", 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