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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0335-2022 |
| Event ID | 88990 |
| Event 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 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 533 consoles and 586 footswitches |
| Recall Reason | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. |
| Device Classification | 20211215 |
| Device Code Info | Product#/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 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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 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| Center Classification Date | 20211206 |
| Recall Initiation Date | 20211028 |
| Recalling Firm | Osteomed, LLC |
| Initial Notification | Letter |
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