Product Safety Recalls

Product Recall Tracker

Osteomed, LLC Recall 88990

Description: OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

Osteomed, LLC Recall 88990 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0335-2022
Event ID88990
Event DescriptionOsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
Product TypeDevices
DistributionWorldwide 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.
Quantity533 consoles and 586 footswitches
Recall ReasonDue to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Device Classification20211215
Device Code InfoProduct#/Brand Name/UDI Code: 450-0005-00 / OsteoMed OsteoPower Power Console 2i / 0084569401211 450-0021-00 / OsteoMed OsteoPower Power Console 2 / 0084569401215 450-0390 / OsteoMed BMF Footswitch / 0084569401215 450-0005-01 / OsteoMed D-Power Control Console 2i / 0084569401211 450-0021-01 / OsteoMed D-Power Control Console 2 / 0084569401211 ECOS-450-0021-00 / Power Control Console 2 / 0084569401211 ECOS-450-0005-00 / Power Control Console 2i / 0084569401211 Serial Numbers: 0332004 450-0005-01 0422006 450-0005-00 0423001 450-0005-01 0434003 S 0434004 S 0434010 S 0443004 0423005 450-0005-01 0449004s 0509004S 0509005S 0506027 0445003 0445005 9912003 0515009 0525014 0532001 0521042 0521045 0535006 0535007 0537031 0537032 0537033 0537034 0540005 0547022 0551022 0551025 0552008 0552009 0611004 0604070 0616001 0616002 0615005 0615009 0615010 0615039 0616003 0616005 0615041 0620004 0620005 0622022 0622023 0633024 0641004 0643068 0645002 0645003 0641009 0648023 0648025 0649002 0649003 0701004 0702021 0701005 0640004 0701006 0701009 0704036 0651097 0714001 0714002 0715029 0715031 0715032 0718003 0719005 0722041 0727024 0727025 0721005 0729044 0734030 0738015 0738017 0740001 0743032 0743033 0743034 0741013 0743036 0743037 0750022 0743038 0750023 0739022 0739023 0803016 0808001 0751032 0811002 0805025 0807056 0820004 0820004 0822030 0832057 0835005 0835004 0839048 0839048 0839049 0839049 0843053 0843054 0852046 0852002 0922072 0931001 0931003 0940011 0944016 0944006 0951020 0949001 1011002 1011003 1004051 1004052 1019002 1004054 1004055 1022048 1019005 1032001 1024002 1034007 1034008 1033010 1034009 1034010 1046013 1041033 1038009 1050036 1047020 1108032 1108033 1109006 1051004 1052014 1123010 1123012 1128022 1128023 1128026 1146012 1152006 0008006 9916005 1152007 1116005 1203041 1152008 1152009 1138003 1138005 1211003 9847002 1213003 1213004 1211005 1216001 1226008 1236044 1236040 1226007 1216002 1233042 1240054 1240055 1233041 1216005 1233045 1242003 1249002 1242004 1249003 1303005 1303002 1306002 1249005 1312002 1312003 1306004 1306005 1306001 0002001 1317012 0023005S 9916008 1240056 1317002 1317004 1336014 1340002 1340005 1341001 1341002 1346001 1346010 1346003 1349003 1349004 1341003 1349005 1351013 1346002 1405005 1405006 1420002 1420003 1405002 1417005 1424008 1424009 1424010 1417006 1434001 1434002 1434003 1434004 1441001 1441002 1441004 1445007 1445008 0244009 0720026 1509001 1509003 1516001 1516002 1518002 1521001 1521001 1521003 1521003 1528001 1528003 1528004 1528005 9942003 1533004 1533005 1528006 1537001 1537002 1537003 1539032 1539033 1539034 1547005 1547009 1543009 1553003 1543010 1604022 1604021 1614009 1134004 1614012 1614014 1604025 1604025 1610028 1610031 1610032 0603007 1410002 1620009 0232001 0548003 1622021 1604024 1610030 1622022 1622023 1622024 1638026 1634018 1634019 1638028 1638029 1634020 1634022 1638034 1638034 1634023 1634023 1634024 1634024 1634025 1634025 1639056 1639056 1639057 1639057 1639058 1644011 1644013 1643017 1644014 1644015 1644015 1643018 1651024 1651026 1644016 1651006 1707004 1707004 1707009 1707009 1651007 1651007 1710003 1710004 1651008 1651009 1651010 1651011 1712018 1710006 1710007 1711062 1711064 1711066 1711067 1715015 1651013 1711060 1711061 1715007 1715008 0751070 1719021 1719022 1719023 1711065 1713012 1721013 0651095 0051007S 1713013 1713014 1713015 1713016 1721015 1721016 1721017 1721018 1721019 1721014 1713017 1713018 1713019 1722009 1737018 1737017 1722011 1722012 1737019 1737020 1743001 1722013 1722014 1722015 1722016 1722017 1722018 1743009 1743007 1743008 1743010 1746027 1734014 1734015 1734016 1746031 1746030 1734017 1734018 1748010 1734019 1734020 1748009 1748001 1748003 1748006 1748007 1817052 1817053 1817054 1817055 1817056 1804002 1804010 1804001 1804003 1804004 1804005 1804007 1804006 1823017 1822008 1822010 1822014 1835012 1835013 1835020 1004053 1838001 1822015 1822016 1848001 1838003 1838004 1838005 1848002 1849017 1849019 1838006 1838007 1838008 1838009 1838010 1846025 1901001 1901002 1848003 1901003 1901004 1904003 1901009 1901010 1846026 1846027 1904001 1904002 1907011 1907012 1907013 1904004 1904005 1904006 1904007 1904008 1904009 1904010 1910031 1910032 1910033 1910034 1928046 1910035 1910036 1910037 1928047 1928048 1910039 1928049 1928050 1934001 1934002 1934003 1934004 1934005 1934006 1915001 1915002 1915003 1915004 1915005 1915006 1915007 1915008 1915009 1915010 1941001 1946002 1941002 1941003 1941004 1946003 1946004 1946005 2002034 1941005 2014016 2014017 2014018 2014019 2014020 1941006 2038001 2038002 1941007 1941008 2038003 2038004 2038005 2038006 2038007 2038008 1941009 2008002 2038009 2008003 2008004 2041001 0639018 2008005 2041002 2008001 2041003 2041006 2041007 2041008 2008007 2008008 2008009 2008010 2014001 2041009 2014002 2014003 2014004 ========================================================= -450-0380 / D-Bi-Directional Master Footswitch / 0084569401215 -450-0350 / D-Uni-Directional Footswitch II / 0084569401215 -450-0360 / D-Bi-Directional Footswitch II / 0084569401215 -450-0370 / D-Uni-Directional Master Footswitch / 0084569401215 Serial Numbers: 0427013 450-0390 0427014 450-0390 0433007 S 0433012 S 0433016 S 0433025 S 0438004S 0438021S 0446004S 0446016S 0446013S 0446014S 0446022S 0519010 0519011 0204001 450-0350 0204002 0433004* 0519025 0526019 0526020 0526021 0526033 0601019 0601020 0605026 0605027 0605033 0605032 0614008 0614019 0614024 0614036 0614037 0614042 0624003 0624006 0624007 0638041 0624020 0638050 0638051 0638060 0643049 0643054 0643064 0643065 0650013 0650014 0650015 0650017 0650020 0650021 0650025 0650028 0650029 0702002 0702004 0708006 0708007 0718025 0718026 0736005 0702015 0739013 0103013 9737001 0739016 0739017 0739018 0743020 0743018 0743023 0743025 0751058 0751057 0751060 0751064 0751065 0751066 0804005 0804006 0804007 0804011 0804015 0813017 0813018 0813018 0813019 0813019 0813020 0819026 0819027 0819029 0831012 0831013 0833013 0833021 0833022 0833023 0833029 0841041 0841049 0843032 0902016 0902017 0902022 0902030 0921020 0927007 0927011 0941009 0948001 0948002 0948020 1004011 1004018 1004019 1004023 1004024 1004025 1018014 1039011 1039015 1039019 1048051 1116012 1116014 1116016 1116017 1116024 1139002 1139007 0029001 1139008 1139009 0106001 1139013 1139014 1139015 1139010 1211021 1139020 1211009 1211010 1211022 1211023 1211024 1211013 1211014 1211015 1030006 1030005 1230006 1230007 1230008 1230009 1211017 1230010 1230021 1230012 1230016 1230018 1230019 1230020 1245011 1245015 1245014 1245017 1245018 1245019 1245024 1245027 1245028 1310021 1310005 1310010 1310008 1310011 1310015 1310018 1310019 1334001 1338016 1338019 1338020 1345001 1345002 1346011 9732005 0004002 s 1346013 1346014 1346016 1346017 1346018 0222025 1018011 1346019 1404005 1346012 1404004 1405011 1408005 1425003 1425004 1425009 1436006 1436007 1436008 1436009 1436011 1436012 1436013 1441007 1441011 1441009 1441012 1447014 1447015 0831008 1501028 1509016 1511021 1511023 1511024 1509014 1509015 1511022 1511025 1516006 1516007 1516008 1516012 1516013 1523003 1523003 1523004 1523005 1523005 1523006 1523006 1523008 1523011 1523010 1528020 1528021 0718022 1536052 1536053 1536057 1536054 1536055 1536061 1537007 1537010 1537011 1537016 1537008 1537009 1537012 1537013 1541041 1541042 1541043 1541045 1541044 1541048 1541050 1541049 1545001 1545003 1545004 1545005 1547001 1547002 1537014 1604031 1604033 1606009 1606010 1606011 1606012 1606013 1606014 1606015 1606016 1606018 1606019 1606021 1606022 1606023 1620018 1620019 1620021 1620022 1620023 1620024 1627001 1627002 1627003 1627005 1627007 1627008 1627009 1630033 1630034 1627010 1630035 1630036 1630037 1630038 1630039 0216010 0718019 1004015 1018020 1606020 1620015 1620020 1630041 1630042 1632001 1632002 1632004 1632005 1634011 1634011 1634009 1634009 1634010 1634010 1639001 1639001 1639002 1639002 1639003 1639003 1639004 1639007 1639007 1639009 1639010 1641015 1641017 1641018 1641019 1641020 1641021 1641021 1651014 1651015 1651016 1651016 1651017 1651017 1651018 1651018 1651020 1651021 1704001 1704002 1704003 1704004 1704005 1704006 1704007 1704008 0142015 1704009 1704010 1711039 1711040 1711042 1721003 1721001 1721010 1711045 1711046 0203013 1713022 1713025 1713026 1713028 1713029 1713030 1721002 1721004 1721005 1721006 1721007 1725010 1725011 1725019 1725012 1725023 1725017 1725018 1725021 1725024 1725022 1731002 1731004 1731005 1731006 1731007 1731008 1731009 1523009 1731010 1731011 1731013 1735011 1735012 1735013 1735014 1735015 1735017 0208003 1735018 1807002 1735019 1735020 1807001 1807004 1807005 1807006 1807008 1812023 1812024 1812026 1812027 1812028 1812029 1812032 1817001 1817002 1817003 1817004 1817005 1847001 1847002 1847004 1847005 0624012 1847006 1847007 1847008 1847009 1847010 1847011 1852001 1852002 1852003 1852004 1852005 1852006 1852007 1852008 1852009 1852010 1903001 0208021s 1903002 1903003 1903004 1903005 1537015 1908005 1908006 1903007 1903008 1903009 1903010 1908007 1908008 1908009 1908010 1903006 1908012 1908014 1911023 1911024 1911025 1911026 1911027 1911028 1911029 1911030 1911032 1920001 1920002 1920004 1920005 1926001 0736019 1926003 1926004 1926005 1926006 1926007 1926008 1926010 1931021 1931022 1931023 1931024 1931025 1931027 1931028 1931030 1946011 1946012 1931029 1946013 1946014 1946015 1946016 1946017 1946018 1946019 1946020 2007008 2007010 2002005 2002010 2007011 0605029 2007012 2007013 2007014 2007015 2013001 2013002 2013003 2013005 2013006 2013007 2013008 2013009 2029003 2013010 2029001 2029002 2029004 2029005 2029006 2029007 2049001 2049004 2049003 2049005 2049006 2049007 2049008 2049009 2049010 1528019 2101011 2101013 2101015 2101016 2101017 2101018 2101019 2101020 2110001 0212002s 2110003 2110005 2110006 2110007 2110008 2110009 2110010 2119001 2119002 2119002 2119006 2119009 2119010 2119003 2119004 2122038 2122039 2122040
Center Classification Date20211206
Recall Initiation Date20211028
Recalling FirmOsteomed, LLC
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.