|
Class 2 Device Recall OsteoMed OsteoPower Power Console |
|
Date Initiated by Firm |
October 28, 2021 |
Create Date |
December 06, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0335-2022 |
Recall Event ID |
88990 |
510(K)Number |
K971692
|
Product Classification |
Handpiece, rotary bone cutting - Product Code KMW
|
Product |
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 |
Code Information |
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
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1317002
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1336014
1340002
1340005
1341001
1341002
1346001
1346010
1346003
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1441001
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0244009
0720026
1509001
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1518002
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1528001
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9942003
1533004
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1537001
1537002
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1539032
1539033
1539034
1547005
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1543009
1553003
1543010
1604022
1604021
1614009
1134004
1614012
1614014
1604025
1604025
1610028
1610031
1610032
0603007
1410002
1620009
0232001
0548003
1622021
1604024
1610030
1622022
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1622024
1638026
1634018
1634019
1638028
1638029
1634020
1634022
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1638034
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1634023
1634024
1634024
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1634025
1639056
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1644014
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1643018
1651024
1651026
1644016
1651006
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1651007
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1651010
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1715007
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0751070
1719021
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1719023
1711065
1713012
1721013
0651095
0051007S
1713013
1713014
1713015
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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
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1904005
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1904007
1904008
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1904010
1910031
1910032
1910033
1910034
1928046
1910035
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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 |
Recalling Firm/ Manufacturer |
Osteomed, LLC 3885 Arapaho Rd Addison TX 75001-4314
|
For Additional Information Contact |
Kathryn A. Jayne 972-677-4766
|
Manufacturer Reason for Recall |
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
|
FDA Determined Cause 2 |
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.
Customer are instructed to:
1) 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.
2) 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.
Fax: 972.677.4766
Email: RecallNotificationGroup@acumed.net
3) Return devices within the scope of the recall and unused consumable inventory and
4) 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.
5) Distributors are being notified of this recall and involved in the communication. Distributors are requested to send their devices back with the RMA provided.
The Recalling Firm is:
initiated 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.
For any questions, contact:
Monday-Friday, 8 AM 5 PM CDT
Kathryn A. Jayne
Sr. Director, Quality Assurance &Regulatory Affairs
OsteoMed LLC
972.677.4766
kathryn.jayne@acumed.net
RecallNotificationGroup@acumed.net
|
Quantity in Commerce |
533 consoles and 586 footswitches |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KMW and Original Applicant = OSTEOMED CORP.
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