{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "162618", "product_res_number": "Z-1337-2018", "event_date_initiated": "2017-08-03", "event_date_posted": "2018-03-20", "recall_status": "Open, Classified", "res_event_number": "79548", "product_code": "EQJ", "product_description": "Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system", "code_info": "Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017", "firm_fei_number": "1037007", "recalling_firm": "Gyrus ACMI, Inc.", "address_1": "2925 Appling Rd", "city": "Bartlett", "state": "TN", "postal_code": "38133-3901", "additional_info_contact": "Customer Service\n901-373-0200", "reason_for_recall": "\"Chattering\" when cutting burrs are used in bone.", "action": "As a result, OSTA will issue a Field Safety Notice (FSN) to all customers that received variable exposure burrs of 5mm or greater diameter. The FSN will\ninform them of the concern and will advise to exercise due caution if using the affected device in proximity to sensitive or vital anatomical structures.\n\nOn September 6, 2017 the firm sent a URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE to the attention of the Surgical Risk Management Department\nfor the following products: MBUR5060FRCV - Burr, 5mm Round Cutting, Variable Exposure, Standard Length, MBUR6060FRCV - Burr, 6mm Round Cutting, Variable Exposure, Standard Length and MBUR7060FRCV - Burr, 7mm Round Cutting, Variable Exposure, Standard Length\tfor All product with an expiration date prior to August 3, 2017\n\nDescription of the problem:\n\nOlympus has become aware of an issue that requires your attention. This letter pertains to the Olympus Round Variable Cutting Burrs (Burrs) referenced above. Our records indicate that you may have purchased affected burrs. \n\nWe are in receipt of a number of non-injury-related complaints that has made Olympus aware of a possibility that the burr may chatter when drilling bone. Although this chatter phenomenon can occur with any type or brand of cutting burr, depending on technique and bone density, Olympus has become aware that the larger diameter variable exposure burrs listed above can exhibit more chatter than other similar devices in some situations, particularly when they are extended to longer lengths. After extensive testing, Olympus has determined that our variable exposure burrs of less than 5mm diameter, and all fixed exposure burr offerings, are not affected by this phenomenon.\n\nBecause of this, Olympus has elected to issue this field safety notice (FSN). Please refer to the enclosure with this letter that cautions of the possibility of the chatter phenomenon in the larger variable offerings. The FSN also recommends that surgeons exercise due caut", "product_quantity": "324", "distribution_pattern": "NM, MI, and TX\nEU, Australia, Japan, and Hong Kong", "openfda": { "k_number": [ "K946332", "K953096", "K893499", "K952609", "K792028", "K960853", "K041985", "K955704", "K951526", "K955294", "K954912", "K950337", "K802503", "K895738", "K953370", "K974232", "K935584", "K161514" ], "device_name": "Bur, Ear, Nose And Throat", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4140", "device_class": "1", "registration_number": [ "3005440795", "1017294", "3013557562", "3003687489", "1061124", "1057421", "3043148563", "9610773", "3012494290", "2649614", "9610617", "2020550", "1030489", "1032347", "3013784566", "2648623", "3005575604", "3013247477", "8030607", "3013893019", "1526611", "1037007", "2648666", "1058584", "3011050570", "3005820796", "3014479313", "3010202439", "3015967359", "9612501", "1926681", "1646747", "3010726901", "9611253", "3014342096", "3009417901", "9680837", "1052728", "9616696", "3021632375", "8040278", "1824199", "2083124", "3003435550", "3002809144", "8010516", "3003790304", "3023464160", "3014334038", "3010173425", "3003418325", "1625507", "3014023545", "1526534", "3010707607", "3010155648", "1526711", "1058084", "3017210488", "3043648115", "3010163695", "1313525", "1836161", "1928237", "3015453963", "3005382983", "9613926", "1058322", "1932180", "1048735", "3018094310", "3008887731", "3005809810", "3006891611", "1649518", "3009460127", "3016678045", "3042940336", "1045834", "1045254", "3032391", "1828288", "3005333358", "3001644167", "3003120897", "3040335671", "3003800209", "3004608878" ], "fei_number": [ "3005440795", "1017294", "3013557562", "3003164255", "3003249645", "3003687489", "3002750084", "3043148563", "3012494290", "2649614", "2020550", "1032347", "3013784566", "2648623", "3005575604", "3013247477", "3002807687", "3007475226", "3002299608", "3013893019", "1526611", "1037007", "2648666", "3011050570", "3005820796", "1000512168", "1000221981", "3014479313", "3015967359", "3002807036", "3006509795", "1926681", "3003495548", "1000022662", "3010726901", "1000119305", "3014342096", "3009417901", "1000477302", "3021632375", "1824199", "2083124", "3003435550", "3002809144", "3003790304", "3023464160", "3014334038", "3003418325", "1625507", "1000219637", "1000160162", "3014023545", "1526534", "3010707607", "3010155648", "1526711", "3017210488", "3043648115", "3001236277", "3010163695", "1928237", "3002808268", "3015453963", "1000307631", "3005382983", "1317628", "1048735", "3018094310", "3008887731", "3005809810", "1000402972", "3006891611", "3004216008", "3009460127", "3016678045", "3042940336", "1045834", "1045254", "1000113735", "1828288", "3004169071", "3005333358", "3001644167", "3003120897", "3040335671", "3002807798", "3003800209", "3004608878" ] } } ] }