{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "84580", "product_res_number": "Z-0083-2010", "event_date_initiated": "2009-08-13", "event_date_posted": "2009-10-28", "recall_status": "Terminated", "event_date_terminated": "2010-01-05", "res_event_number": "53073", "product_code": "HBE", "k_numbers": [ "K011444", "K080802" ], "product_description": "Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP.\n\nIndicated to cut and shape bone including bones of the spine and cranium.", "code_info": "EMAX2-FP Serial Numbers: C26302250301, C26302250302, C26302250303, C26302250304, 5044044307, 31495607, 32380602, 31832209, 31832202 and 32366805; and  EPLUS-FP Serial Numbers: C26302200804 , C26302200802, C27302221701 and C08301701901.", "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 Ext. 500", "reason_for_recall": "The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal", "root_cause_description": "Device Design", "action": "Anspach issued an \"Urgent Product Removal\" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm.\n\nFor further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.", "product_quantity": "14", "distribution_pattern": "Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).", "openfda": { "k_number": [ "K984035", "K903664", "K162542", "K202120", "K080802", "K252060", "K172709", "K130755", "K223199", "K253627", "K905097", "K002903", "K190172", "K111520", "K121264", "K042783", "K153519", "K022942", "K232684", "K143320", "K070876", "K911819", "K143540", "K930229", "K230619", "K213208", "K943541", "K911812", "K161704", "K210377", "K182527", "K250374", "K170442", "K081475", "K203739", "K881418", "K873692", "K252662", "K250380", "K182436", "K062842", "K900388", "K072315", "K880601", "K050628", "K213072", "K014060", "K251433", "K191049", "K922299", "K191479", "K902703", "K875224", 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"medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2" } } ] }