{ "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": "176316", "product_res_number": "Z-0110-2020", "event_date_initiated": "2018-07-24", "event_date_created": "2019-10-09", "recall_status": "Terminated", "event_date_terminated": "2020-10-01", "res_event_number": "83768", "product_code": "NKG", "k_numbers": [ "K171444" ], "product_description": "YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA\n3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm,\n4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm,\n4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm)\n\nCatalog Numbers 7601-03512, 7601-03514,\n7601-03532, 7601-03534,\n7601-03538L, 7601-03540L,\n7601-04016L, 7601-04018L,\n7601-04020L, 7601-04022L,\n7601-04024L, 7601-04026L,\n7601-04028L, 7601-04030,\n7601-05022, 7601-05028,\n7601-05030", "code_info": "Lots FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU, FUWV, FUWW, FUXK, FUXL,FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, FUXV", "firm_fei_number": "3008599177", "recalling_firm": "K2M, Inc", "address_1": "600 Hope Pkwy SE", "city": "Leesburg", "state": "VA", "postal_code": "20175-4428", "additional_info_contact": "Customer Contact\n201-749-8090", "reason_for_recall": "Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.", "root_cause_description": "Process control", "action": "K2M notified customers with a Recall Notification Letter dated July 24, 2018. The letter instructed customers to locate and segregate recalled product, complete a tracking/verification form, and return the product to K2M.", "product_quantity": "364", "distribution_pattern": "Distributed to accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, and WA.. Foreign distribution to Australia.", "openfda": { "k_number": [ "K252327", "K211710", "K233366", "K171834", "K173047", "K183383", "K152211", "K181603", "K203319", "K192014", "K150570", "K232167", "K153370", "K153336", "K231840", "K170804", "K213871", "K172495", "K171444", "K142838", "K160428", "K161478", "K172194", "K143471", "K151031", "K182837", "K200571", "K250866", "K230614", "K254045", "K213654", "K153169", "K172594", "K211993", "K190631", "K152338", "K180025", "K150539", "K221307", "K151705", "K162300", "K200896", "K250332", "K253129", "K171250", "K162266", "K162575", "K201481", "K203125", "K151224", "K170647", "K161591", "K150474", "K192013", "K254165", "K150650", "K153386", "K162639", "K181949", "K191553", "K162136", "K193129", "K220810", "K190071", "K181350", "K210887", "K150918", "K220570", "K220658", "K231850", "K233078", "K160756", "K223852", "K151885", "K200936", "K200793", "K193615", "K180851", "K242674", "K192646", "K233989", "K223764", "K172279", "K242516", "K163375", 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"3004638532" ], "device_name": "Posterior Cervical Screw System", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3075", "device_class": "2" } } ] }