{ "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": "124873", "product_res_number": "Z-0715-2014", "event_date_initiated": "2012-03-29", "event_date_posted": "2014-01-10", "recall_status": "Terminated", "event_date_terminated": "2017-10-12", "res_event_number": "67177", "product_code": "HBE", "k_numbers": [ "K042783" ], "product_description": "Anspach MCA Cutting Burr, DFU Rx Only\r\n\r\nDesigned for cutting and shaping delicate bone, primarily in otology procedures", "code_info": "ALL LOTS for product code 18-0001", "firm_fei_number": "1045834", "recalling_firm": "The Anspach Effort, Inc.", "address_1": "4500 Riverside Drive", "city": "Palm Beach Gardens", "state": "FL", "postal_code": "33410-4235", "additional_info_contact": "561-627-1080", "reason_for_recall": "Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.", "root_cause_description": "Error in labeling", "action": "Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email customer.support@synthes.com or ProductSupportTeam@Synthes.com.\r\nFor questions regarding this recall call 561-627-1020.", "product_quantity": "492 (321 US)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.", "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", 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"medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2" } } ] }