{ "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": "86902", "product_res_number": "Z-0538-2010", "event_date_initiated": "2009-11-06", "event_date_posted": "2009-12-16", "recall_status": "Terminated", "event_date_terminated": "2010-03-02", "res_event_number": "53943", "product_code": "HBE", "k_numbers": [ "K062842" ], "product_description": "Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141.\n\nDISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. \n\nA single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.", "code_info": "Lots: 535933, 536306 and 537407.", "firm_fei_number": "1032347", "recalling_firm": "Biomet Microfixation, Inc.", "address_1": "1520 Tradeport Dr", "city": "Jacksonville", "state": "FL", "postal_code": "32218-2480", "additional_info_contact": "Laura Sabo\n904-741-4400", "reason_for_recall": "The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).", "root_cause_description": "Process change control", "action": "Consignees were notified of the recall by a combination of telephone calls, letters, and emails during the week of November 16, 2009. Customers were instructed to complete the Inventory Reconciliation Sheet and fax (1-904-741-9425) to the firm. Customers who further distributed the affected product was instructed to notify recipients of the recall. Direct questions about the recall to Biomet Microfixation, Inc. by calling 1-800-874-7711 or 1-904-741-4400, extension 468, Monday through Friday, 8 a.m. to 4 p.m. Eastern Standard Time.", "product_quantity": "283 pieces", "distribution_pattern": "Worldwide Distribution -- United States (including Puerto Rico), Australia, Brazil, Canada, Chile, Europe, France, Germany, Greece, Japan, Lebanon, Spain, and the United Arab Emirates.", "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", 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"medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2" } } ] }