{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190208", "product_res_number": "Z-0335-2022", "event_date_initiated": "2021-10-28", "event_date_created": "2021-12-06", "recall_status": "Open, Classified", "res_event_number": "88990", "product_code": "KMW", "k_numbers": [ "K971692" ], "product_description": "OsteoMed OsteoPower Power Console:\n\n-OsteoMed OsteoPower Power Console 2 REF 450-0021-00\n-OsteoMed D-Power Control Console 2 REF 450-0021-01\n-Power Control Console 2 REF ECOS-450-0021-00\n\n-OsteoMed OsteoPower Power Console 2i REF 450-0005-00\n-OsteoMed D-Power Control Console 2i REF 450-0005-01\n-Power Control Console 2i REF ECOS-450-0005-00\n\nOsteoMed Footswitches:\n-OsteoMed BMF Footswitch REF 450-0390\n-D-Bi-Directional Master Footswitch REF 450-0380\n-D-Uni-Directional Footswitch II REF 450-0350\n-D-Bi-Directional Footswitch II REF 450-0360\n-D-Uni-Directional Master Footswitch REF 450-0370", "code_info": "Product#/Brand Name/UDI Code:\n450-0005-00\t/ OsteoMed OsteoPower Power Console 2i / 0084569401211\n450-0021-00 / OsteoMed OsteoPower Power Console 2 / 0084569401215\n450-0390 / OsteoMed BMF Footswitch / 0084569401215\n450-0005-01 / OsteoMed D-Power Control Console 2i / 0084569401211\n450-0021-01 / OsteoMed D-Power Control Console 2 / 0084569401211\nECOS-450-0021-00 / Power Control Console 2 / 0084569401211\nECOS-450-0005-00 / Power Control Console 2i / 0084569401211\n\nSerial Numbers:\n0332004 450-0005-01\n0422006 450-0005-00\n0423001 450-0005-01\n0434003 S\n0434004 S\n0434010 S\n0443004\n0423005 450-0005-01\n0449004s\n0509004S\n0509005S\n0506027\n0445003\n0445005\n9912003\n0515009\n0525014\n0532001\n0521042\n0521045\n0535006\n0535007\n0537031\n0537032\n0537033\n0537034\n0540005\n0547022\n0551022\n0551025\n0552008\n0552009\n0611004\n0604070\n0616001\n0616002\n0615005\n0615009\n0615010\n0615039\n0616003\n0616005\n0615041\n0620004\n0620005\n0622022\n0622023\n0633024\n0641004\n0643068\n0645002\n0645003\n0641009\n0648023\n0648025\n0649002\n0649003\n0701004\n0702021\n0701005\n0640004\n0701006\n0701009\n0704036\n0651097\n0714001\n0714002\n0715029\n0715031\n0715032\n0718003\n0719005\n0722041\n0727024\n0727025\n0721005\n0729044\n0734030\n0738015\n0738017\n0740001\n0743032\n0743033\n0743034\n0741013\n0743036\n0743037\n0750022\n0743038\n0750023\n0739022\n0739023\n0803016\n0808001\n0751032\n0811002\n0805025\n0807056\n0820004\n0820004\n0822030\n0832057\n0835005\n0835004\n0839048\n0839048\n0839049\n0839049\n0843053\n0843054\n0852046\n0852002\n0922072\n0931001\n0931003\n0940011\n0944016\n0944006\n0951020\n0949001\n1011002\n1011003\n1004051\n1004052\n1019002\n1004054\n1004055\n1022048\n1019005\n1032001\n1024002\n1034007\n1034008\n1033010\n1034009\n1034010\n1046013\n1041033\n1038009\n1050036\n1047020\n1108032\n1108033\n1109006\n1051004\n1052014\n1123010\n1123012\n1128022\n1128023\n1128026\n1146012\n1152006\n0008006\n9916005\n1152007\n1116005\n1203041\n1152008\n1152009\n1138003\n1138005\n1211003\n9847002\n1213003\n1213004\n1211005\n1216001\n1226008\n1236044\n1236040\n1226007\n1216002\n1233042\n1240054\n1240055\n1233041\n1216005\n1233045\n1242003\n1249002\n1242004\n1249003\n1303005\n1303002\n1306002\n1249005\n1312002\n1312003\n1306004\n1306005\n1306001\n0002001\n1317012\n0023005S\n9916008\n1240056\n1317002\n1317004\n1336014\n1340002\n1340005\n1341001\n1341002\n1346001\n1346010\n1346003\n1349003\n1349004\n1341003\n1349005\n1351013\n1346002\n1405005\n1405006\n1420002\n1420003\n1405002\n1417005\n1424008\n1424009\n1424010\n1417006\n1434001\n1434002\n1434003\n1434004\n1441001\n1441002\n1441004\n1445007\n1445008\n0244009\n0720026\n1509001\n1509003\n1516001\n1516002\n1518002\n1521001\n1521001\n1521003\n1521003\n1528001\n1528003\n1528004\n1528005\n9942003\n1533004\n1533005\n1528006\n1537001\n1537002\n1537003\n1539032\n1539033\n1539034\n1547005\n1547009\n1543009\n1553003\n1543010\n1604022\n1604021\n1614009\n1134004\n1614012\n1614014\n1604025\n1604025\n1610028\n1610031\n1610032\n0603007\n1410002\n1620009\n0232001\n0548003\n1622021\n1604024\n1610030\n1622022\n1622023\n1622024\n1638026\n1634018\n1634019\n1638028\n1638029\n1634020\n1634022\n1638034\n1638034\n1634023\n1634023\n1634024\n1634024\n1634025\n1634025\n1639056\n1639056\n1639057\n1639057\n1639058\n1644011\n1644013\n1643017\n1644014\n1644015\n1644015\n1643018\n1651024\n1651026\n1644016\n1651006\n1707004\n1707004\n1707009\n1707009\n1651007\n1651007\n1710003\n1710004\n1651008\n1651009\n1651010\n1651011\n1712018\n1710006\n1710007\n1711062\n1711064\n1711066\n1711067\n1715015\n1651013\n1711060\n1711061\n1715007\n1715008\n0751070\n1719021\n1719022\n1719023\n1711065\n1713012\n1721013\n0651095\n0051007S\n1713013\n1713014\n1713015\n1713016\n1721015\n1721016\n1721017\n1721018\n1721019\n1721014\n1713017\n1713018\n1713019\n1722009\n1737018\n1737017\n1722011\n1722012\n1737019\n1737020\n1743001\n1722013\n1722014\n1722015\n1722016\n1722017\n1722018\n1743009\n1743007\n1743008\n1743010\n1746027\n1734014\n1734015\n1734016\n1746031\n1746030\n1734017\n1734018\n1748010\n1734019\n1734020\n1748009\n1748001\n1748003\n1748006\n1748007\n1817052\n1817053\n1817054\n1817055\n1817056\n1804002\n1804010\n1804001\n1804003\n1804004\n1804005\n1804007\n1804006\n1823017\n1822008\n1822010\n1822014\n1835012\n1835013\n1835020\n1004053\n1838001\n1822015\n1822016\n1848001\n1838003\n1838004\n1838005\n1848002\n1849017\n1849019\n1838006\n1838007\n1838008\n1838009\n1838010\n1846025\n1901001\n1901002\n1848003\n1901003\n1901004\n1904003\n1901009\n1901010\n1846026\n1846027\n1904001\n1904002\n1907011\n1907012\n1907013\n1904004\n1904005\n1904006\n1904007\n1904008\n1904009\n1904010\n1910031\n1910032\n1910033\n1910034\n1928046\n1910035\n1910036\n1910037\n1928047\n1928048\n1910039\n1928049\n1928050\n1934001\n1934002\n1934003\n1934004\n1934005\n1934006\n1915001\n1915002\n1915003\n1915004\n1915005\n1915006\n1915007\n1915008\n1915009\n1915010\n1941001\n1946002\n1941002\n1941003\n1941004\n1946003\n1946004\n1946005\n2002034\n1941005\n2014016\n2014017\n2014018\n2014019\n2014020\n1941006\n2038001\n2038002\n1941007\n1941008\n2038003\n2038004\n2038005\n2038006\n2038007\n2038008\n1941009\n2008002\n2038009\n2008003\n2008004\n2041001\n0639018\n2008005\n2041002\n2008001\n2041003\n2041006\n2041007\n2041008\n2008007\n2008008\n2008009\n2008010\n2014001\n2041009\n2014002\n2014003\n2014004\n\n=========================================================\n-450-0380 / D-Bi-Directional Master Footswitch / 0084569401215\n-450-0350 / D-Uni-Directional Footswitch II / 0084569401215\n-450-0360 / D-Bi-Directional Footswitch II / 0084569401215\n-450-0370 / D-Uni-Directional Master Footswitch / 0084569401215\n\nSerial Numbers:\n0427013 450-0390\n0427014 450-0390\n0433007 S\n0433012 S\n0433016 S\n0433025 S\n0438004S\n0438021S\n0446004S\n0446016S\n0446013S\n0446014S\n0446022S\n0519010\n0519011\n0204001 450-0350\n0204002\n0433004*\n0519025\n0526019\n0526020\n0526021\n0526033\n0601019\n0601020\n0605026\n0605027\n0605033\n0605032\n0614008\n0614019\n0614024\n0614036\n0614037\n0614042\n0624003\n0624006\n0624007\n0638041\n0624020\n0638050\n0638051\n0638060\n0643049\n0643054\n0643064\n0643065\n0650013\n0650014\n0650015\n0650017\n0650020\n0650021\n0650025\n0650028\n0650029\n0702002\n0702004\n0708006\n0708007\n0718025\n0718026\n0736005\n0702015\n0739013\n0103013\n9737001\n0739016\n0739017\n0739018\n0743020\n0743018\n0743023\n0743025\n0751058\n0751057\n0751060\n0751064\n0751065\n0751066\n0804005\n0804006\n0804007\n0804011\n0804015\n0813017\n0813018\n0813018\n0813019\n0813019\n0813020\n0819026\n0819027\n0819029\n0831012\n0831013\n0833013\n0833021\n0833022\n0833023\n0833029\n0841041\n0841049\n0843032\n0902016\n0902017\n0902022\n0902030\n0921020\n0927007\n0927011\n0941009\n0948001\n0948002\n0948020\n1004011\n1004018\n1004019\n1004023\n1004024\n1004025\n1018014\n1039011\n1039015\n1039019\n1048051\n1116012\n1116014\n1116016\n1116017\n1116024\n1139002\n1139007\n0029001\n1139008\n1139009\n0106001\n1139013\n1139014\n1139015\n1139010\n1211021\n1139020\n1211009\n1211010\n1211022\n1211023\n1211024\n1211013\n1211014\n1211015\n1030006\n1030005\n1230006\n1230007\n1230008\n1230009\n1211017\n1230010\n1230021\n1230012\n1230016\n1230018\n1230019\n1230020\n1245011\n1245015\n1245014\n1245017\n1245018\n1245019\n1245024\n1245027\n1245028\n1310021\n1310005\n1310010\n1310008\n1310011\n1310015\n1310018\n1310019\n1334001\n1338016\n1338019\n1338020\n1345001\n1345002\n1346011\n9732005\n0004002 s\n1346013\n1346014\n1346016\n1346017\n1346018\n0222025\n1018011\n1346019\n1404005\n1346012\n1404004\n1405011\n1408005\n1425003\n1425004\n1425009\n1436006\n1436007\n1436008\n1436009\n1436011\n1436012\n1436013\n1441007\n1441011\n1441009\n1441012\n1447014\n1447015\n0831008\n1501028\n1509016\n1511021\n1511023\n1511024\n1509014\n1509015\n1511022\n1511025\n1516006\n1516007\n1516008\n1516012\n1516013\n1523003\n1523003\n1523004\n1523005\n1523005\n1523006\n1523006\n1523008\n1523011\n1523010\n1528020\n1528021\n0718022\n1536052\n1536053\n1536057\n1536054\n1536055\n1536061\n1537007\n1537010\n1537011\n1537016\n1537008\n1537009\n1537012\n1537013\n1541041\n1541042\n1541043\n1541045\n1541044\n1541048\n1541050\n1541049\n1545001\n1545003\n1545004\n1545005\n1547001\n1547002\n1537014\n1604031\n1604033\n1606009\n1606010\n1606011\n1606012\n1606013\n1606014\n1606015\n1606016\n1606018\n1606019\n1606021\n1606022\n1606023\n1620018\n1620019\n1620021\n1620022\n1620023\n1620024\n1627001\n1627002\n1627003\n1627005\n1627007\n1627008\n1627009\n1630033\n1630034\n1627010\n1630035\n1630036\n1630037\n1630038\n1630039\n0216010\n0718019\n1004015\n1018020\n1606020\n1620015\n1620020\n1630041\n1630042\n1632001\n1632002\n1632004\n1632005\n1634011\n1634011\n1634009\n1634009\n1634010\n1634010\n1639001\n1639001\n1639002\n1639002\n1639003\n1639003\n1639004\n1639007\n1639007\n1639009\n1639010\n1641015\n1641017\n1641018\n1641019\n1641020\n1641021\n1641021\n1651014\n1651015\n1651016\n1651016\n1651017\n1651017\n1651018\n1651018\n1651020\n1651021\n1704001\n1704002\n1704003\n1704004\n1704005\n1704006\n1704007\n1704008\n0142015\n1704009\n1704010\n1711039\n1711040\n1711042\n1721003\n1721001\n1721010\n1711045\n1711046\n0203013\n1713022\n1713025\n1713026\n1713028\n1713029\n1713030\n1721002\n1721004\n1721005\n1721006\n1721007\n1725010\n1725011\n1725019\n1725012\n1725023\n1725017\n1725018\n1725021\n1725024\n1725022\n1731002\n1731004\n1731005\n1731006\n1731007\n1731008\n1731009\n1523009\n1731010\n1731011\n1731013\n1735011\n1735012\n1735013\n1735014\n1735015\n1735017\n0208003\n1735018\n1807002\n1735019\n1735020\n1807001\n1807004\n1807005\n1807006\n1807008\n1812023\n1812024\n1812026\n1812027\n1812028\n1812029\n1812032\n1817001\n1817002\n1817003\n1817004\n1817005\n1847001\n1847002\n1847004\n1847005\n0624012\n1847006\n1847007\n1847008\n1847009\n1847010\n1847011\n1852001\n1852002\n1852003\n1852004\n1852005\n1852006\n1852007\n1852008\n1852009\n1852010\n1903001\n0208021s\n1903002\n1903003\n1903004\n1903005\n1537015\n1908005\n1908006\n1903007\n1903008\n1903009\n1903010\n1908007\n1908008\n1908009\n1908010\n1903006\n1908012\n1908014\n1911023\n1911024\n1911025\n1911026\n1911027\n1911028\n1911029\n1911030\n1911032\n1920001\n1920002\n1920004\n1920005\n1926001\n0736019\n1926003\n1926004\n1926005\n1926006\n1926007\n1926008\n1926010\n1931021\n1931022\n1931023\n1931024\n1931025\n1931027\n1931028\n1931030\n1946011\n1946012\n1931029\n1946013\n1946014\n1946015\n1946016\n1946017\n1946018\n1946019\n1946020\n2007008\n2007010\n2002005\n2002010\n2007011\n0605029\n2007012\n2007013\n2007014\n2007015\n2013001\n2013002\n2013003\n2013005\n2013006\n2013007\n2013008\n2013009\n2029003\n2013010\n2029001\n2029002\n2029004\n2029005\n2029006\n2029007\n2049001\n2049004\n2049003\n2049005\n2049006\n2049007\n2049008\n2049009\n2049010\n1528019\n2101011\n2101013\n2101015\n2101016\n2101017\n2101018\n2101019\n2101020\n2110001\n0212002s\n2110003\n2110005\n2110006\n2110007\n2110008\n2110009\n2110010\n2119001\n2119002\n2119002\n2119006\n2119009\n2119010\n2119003\n2119004\n2122038\n2122039\n2122040", "firm_fei_number": "2027754", "recalling_firm": "Osteomed, LLC", "address_1": "3885 Arapaho Rd", "city": "Addison", "state": "TX", "postal_code": "75001-4314", "additional_info_contact": "Kathryn A. Jayne\n972-677-4766", "reason_for_recall": "Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.", "root_cause_description": "Device Design", "action": "On 10/28/2021, the firm initiated a telephone communication and sent an \"URGENT Medical Device Recall\" communication/letter informing customers that the Power Consoles and Footswitches do not meet the current electrical and safety testing requirements for medical devices per IEC 60601 and as such, could result in possible electrical shocks to patients and users and potentially cause interference with other devices.\n\nCustomer are instructed to:\n1) Immediately discontinue use of devices by powering off, unplug the device and move the device to a separate room away from the point of care.\n2) Review the Notification letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax within the 7 calendar days. \nFax: 972.677.4766\nEmail: RecallNotificationGroup@acumed.net\n3) Return devices within the scope of the recall and unused consumable inventory and\n4) immediately discontinuing use of the devices within the scope of this voluntary recall. OsteoMed will provide FedEx shipping account information. In addition, we have issued a Return Material Authorization specific to your facility. This is located on the Acknowledgement and Receipt Form. \n5) Distributors are being notified of this recall and involved in the communication. Distributors are requested to send their devices back with the RMA provided.\n\nThe Recalling Firm is:\ninitiated this voluntary recall and is requesting that all affected units be removed from point of care to prevent use of the device. The Recalling Firm will provide return information and point of care destruction should customers opt to dispose of the device at their facilities.\n\nFor any questions, contact:\nMonday-Friday, 8 AM 5 PM CDT\nKathryn A. Jayne\nSr. Director, Quality Assurance &Regulatory Affairs\nOsteoMed LLC\n972.677.4766\nkathryn.jayne@acumed.net \nRecallNotificationGroup@acumed.net", "product_quantity": "533 consoles and 586 footswitches", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI. The countries of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, Germany, Guatemala, Indonesia, Italy, Japan, Korea, Kuwait, Lithuania, Malaysia, Mexico, Russia, Spain, Thailand, Turkey, United Kingdom, and Venezuela.", "openfda": { "k_number": [ "K932255", "K971692", "K080939", "K970953", "K162544", "K862110", "K994298", "K211584", "K171155" ], "registration_number": [ "3006540014", "3011276344", "3011824442", "3014683120", "3011300255", "2027754", "3009161350", "3014953747", "1422375", "3030126955", "3010185635", "1054713", "3007279848", "9611253", "9681479", "3030235916", "1649518" ], "fei_number": [ "3006540014", "1000139790", "3003755849", "1000114111", "3011276344", "3011824442", "3014683120", "3011300255", "2027754", "3009161350", "3014953747", "3001236277", "3030126955", "3010185635", "3007279848", "3030235916", "3002807687" ], "device_name": "Handpiece, Rotary Bone Cutting", "medical_specialty_description": "Dental", "regulation_number": "872.4120", "device_class": "2" } } ] }