{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "151391", "product_res_number": "Z-0871-2017", "event_date_initiated": "2016-11-30", "event_date_posted": "2016-12-21", "recall_status": "Terminated", "event_date_terminated": "2017-06-01", "res_event_number": "75819", "product_code": "HBE", "product_description": "8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile\nThe Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases.\nEach cutting accessory consists of:\n\" A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end.\n\" A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.", "code_info": "Lot Number:16038017, Product Number: 8470-009-040", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E Milham Ave", "city": "Portage", "state": "MI", "postal_code": "49002-9704", "additional_info_contact": "Kelly Jo Davis\n269-323-7700", "reason_for_recall": "Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.", "root_cause_description": "Storage", "action": "The firm, Stryker Instruments, sent an \"URGENT MEDICAL DEVICE RECALL NOTIFICATION\" letter dated November 2016 to its Customers Overnight service, FedEx on November 30, 2016. The letter described the product, problems and actions to be taken. Stryker Sales Representatives and Stryker International will be notified via email. Customers are instructed to do the following: \n1. Immediately review the Recall Notification.\n2. Check all stock areas and/or operating room storage to determine how many affected Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Burs.\n3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of the notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any\naffected product on hand. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to StrykerInstrumentsRecalls@stryker.com.\nNote: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification.\n4. If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF.\n5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to StrykerInstrumentsRecalls@stryker.com.\n6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be\nissued to your account.\n\nRecalled products will be destroyed, packaging will be defaced, opened and discarded. Product will be discarded.\n\nFor questions regarding this recall, please contact Stryker Instruments: StrykerInstrumentsRecalls@stryker.com, or", "product_quantity": "1,257 in total", "distribution_pattern": "Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).", "openfda": { "k_number": [ "K170442", "K182527", "K143320", "K190172", "K202120", "K223199", "K250380", "K032303", "K213208", "K191049", "K252662", "K042783", "K935861", "K911819", "K943541", "K253627", "K050628", "K062842", "K022942", "K250815", "K900388", "K121264", "K250374", "K210377", "K111520", "K130755", "K182436", "K902703", "K161704", "K113476", "K905097", "K143540", "K081475", "K213072", "K132436", "K183545", "K880601", "K203739", "K232684", "K162542", "K143399", "K183203", "K252060", 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"Drills, Burrs, Trephines & Accessories (Simple, Powered)", "medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2" } } ] }