{ "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": "122056", "product_res_number": "Z-0654-2014", "event_date_initiated": "2013-04-25", "event_date_posted": "2014-01-09", "recall_status": "Terminated", "event_date_terminated": "2015-07-20", "res_event_number": "66323", "product_code": "HSZ", "k_numbers": [ "K955084" ], "product_description": "***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. \r\nIntended for cutting and shaping bone.", "code_info": "Serial Number 31496602", "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": "Denise DeLuigi\n561-494-3711", "reason_for_recall": "The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..", "root_cause_description": "Component design/selection", "action": "The firm, Anspach sent an \"URGENT\" Medical Devics Removal\" letter dated April 24, 2013, to its customers. Customer Immediate Actions: 1. Screen your current inventory and return all Anspach Pneumatic Drill System without a pressure Relief valve (PRV) from your inventory. 2. If you have any product listed on the attached form to arrange for immediate return and replacements. 3. complete the attached Customer Reply form indicating the product being returned. 4. Upon receipt of a replacement product, equipment being returned must be received by Anspach within 10 business days of the replacement request. Should you have any queries, please contact Anspach Product Support at (800) 327-6887.", "product_quantity": "2,785", "distribution_pattern": "Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.", "openfda": { "k_number": [ "K844131", "K881954", "K930784", "K790645", "K940276", "K884492", "K781979", "K903713", "K915139", "K905277", "K914845", "K934336", "K922661", "K905027", "K954080", "K840831", "K880074", "K885229", "K930785", "K991588", "K900210", "K970345", "K831756", "K803284", "K880324", "K942760", "K851443", "K935367", "K871287", "K895121", "K880881", "K811005", "K934431", "K972860", "K905187", "K941681", "K871891", "K872550", "K811834", "K913559", "K885273", "K800275", "K791056", "K901455", "K861405", "K904949", "K944590", "K780139", "K772324", "K913629", "K955084", "K881250", "K801329", "K844130", "K926547", "K864314" ], "registration_number": [ "1038671", "3005382983", "1526534", "1226544", "3015399803", "3018094310", "1058584", "2029275", "3042243169", "1000200989", "3016172274", "3020155054", "3014479313", "3008808049", "1045834", "3007997036", "1834331", "2648666", "1822565", "1017294", "3011683674", "2183911", "9611102", "1954316", "3031240334", "1047843", "3036756245", "1836161", "3009417901", "2244478", "3004464325", "3025603301", "3015542154", "3015440604", "1045254", "1649518", "1828464", "1625507", "3008868758", "3013176080", "1833986", "1825034", "3010202439", "3035366890", "3033509898", "3015967359", "3009812190", "3008951116", "3017196117", "3009106092", "3013011598", "3005061536", "3015882686", "2025102", "3008812560", "1061124", "3002807310", "3015207155", "3009227834", "2020550", "3000270450", "8030607", "2647346" ], "fei_number": [ "1038671", "3003128516", "3005382983", "1526534", "1000219637", "3004949275", "1000139987", "3001236277", "3002750084", "3015399803", "3018094310", "3042243169", "1000200989", "1000220733", "3016172274", "3020155054", "3007475226", "1000306431", "3008808049", "3007997036", "1045834", "3006509795", "3014479313", "1017294", "1000136269", "3011683674", "3022270316", "3031240334", "1047843", "2648666", "3036756245", "3009417901", "3004464325", "3025603301", "3015542154", "3015440604", "1045254", "1828464", "1625507", "3008868758", "3013176080", "1825034", "1000512168", "3035366890", "3033509898", "3015967359", "3008951116", "3005061536", "3017196117", "3009106092", "1000116142", "3013011598", "3015882686", "3004873266", "3008812560", "3002807310", "3015207155", "3009227834", "1000306340", "3002808001", "2020550", "3000270450", "2647346" ], "device_name": "Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4820", "device_class": "1" } } ] }