{ "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": "210037", "product_res_number": "Z-0063-2025", "event_date_initiated": "2024-09-05", "event_date_posted": "2024-10-11", "recall_status": "Open, Classified", "res_event_number": "95342", "product_code": "HBE", "k_numbers": [ "K143320" ], "product_description": "1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,\ndecorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications\nCatalog Number: 5820-066-012", "code_info": "GTIN: 04546540362346 \nLot number: 22329017", "firm_fei_number": "3015967359", "recalling_firm": "Stryker Corporation", "address_1": "1941 Stryker Way", "city": "Portage", "state": "MI", "postal_code": "49002-9711", "additional_info_contact": "SAME\n269-800-1941", "reason_for_recall": "May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.", "root_cause_description": "Process control", "action": "Stryker issued Urgent Medical Device Recall Letter on 9/5/24 via FedEx 2-day to\nRecall Department, Materials Manager, OR Director, Risk Manager. Letter states reason for recall, health risk and action to take:\nActions needed\n1. Immediately review your inventory to locate and quarantine any affected products at your facility.\n2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email\nInstruments.Recalls@stryker.com.\n3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand.\n4. A replacement will be provided upon receipt of the recalled product.\n5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly.\nIf you have any questions about this matter, contact Stryker Instruments recall team directly by calling (269) 568-1481 or email at Instruments.Recalls@stryker.com.", "product_quantity": "307 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Columbia.", "openfda": { "k_number": [ "K903664", "K170442", "K250374", "K161704", "K213208", "K213454", "K230619", "K050628", "K182436", "K062842", "K203739", "K873692", "K902703", "K880601", "K252662", "K111520", "K162542", "K943541", "K143399", "K113476", "K153519", "K922299", "K190172", "K123270", "K202120", "K253627", "K191479", "K250815", "K223199", "K191049", "K143320", "K984035", "K252060", "K935861", "K911812", "K130755", "K900388", "K250380", "K121264", "K072315", "K143540", "K251433", "K930229", "K132436", "K881418", "K080802", "K905097", "K042783", "K183203", "K022942", "K040076", "K232684", "K183545", 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