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U.S. Department of Health and Human Services

Class 3 Device Recall Stryker Instruments

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 Class 3 Device Recall Stryker Instrumentssee related information
Date Initiated by FirmMarch 25, 2015
Date PostedMay 07, 2015
Recall Status1 Terminated 3 on July 08, 2015
Recall NumberZ-1587-2015
Recall Event ID 70933
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
ProductUniversal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.
Code Information Part No. 7110-120-000; Affected serial numbers as follows: 1234701323, 1402902743, 1402902893, 1221503173, 326305393, 1217705113, 1315004963, 1222700863, 1326305403, 1217705123, 1315005013, 1222701093, 1217705283, 1324801023, 1217705083, 1322600723, 1217900123, 1324801083, 1217705093, 1305900203, 1210305253, 1407105433, 1217705133, 1306611063, 1400202023, 1409403273, 1334302313, 1307105733, 1400202103, 1205304123, 1334302333, 1307801973, 1402104293, 1205304133, 1334302363, 1307801983, 1402205583, 1207500553, 1334302413, 1307801993, 1301614823, 1426000013, 1334302433, 1207500593, 1301700663, 1326902543, 1305903843, 1207500603, 1326902613, 1326902563, 1333709623, 1302910113, 1327000033, 1327000253, 1333709633, 1302910133, 1327000073, 1232007733, 1333904723, 1305601713, 1317000743, 1317801313, 1333904773, 1305601723, 1302904613, 1317801323, 1333904813, 1305601733, 1303706253, 1214307613, 1333904873, 1323407973, 1314100963, 1214307753, 1317801293, 1323408113,  1314101093, 1214307763, 1325205193, 1323400563, 1235214993, 1317601493, 1325205203, 1323400553,  1235301413, 1317601503, 1326202573, 1323408133, 1210703413, 1317601513, 1326202643, 1323400503, 1326902663, 1317601573, 1326202853, 1406900423, 1229005743, 1317601613, 1221503193, 1131901973,  1301801283, 1317601633, 1221503243, 1132100013, 1317819563, 1317601693, 1204005873, 1210703303, 1329401733, 1319703043, 1205304433, 1210703333,  1400205393, 1314908463, 1217900203, 1302904713,  1401603423, 1314908763, 1221503143 & 1303706283      1317000303 1403013923 1327200633 1314100863 1317000523 1407601743 1221503113 1214307743 1207500493 1407601793 1222700883 1130600583 1207500523 1418913743 1222700973 1206101153 1207500533 1418913753 1222701063 1316303583 1207500543 1210703193 1317819693 1316303623 1227519993 1403013973 1327000133 1316303633 1300700303 1403013983 1327000143 1316303683 1300700313 1403013993 1307801883 1331806133 1300700323 1403014013 1210703133 1317000103 1327000283 1407612643 1214307963 1424507203 1327000293 1407704073 1410600103 1235301433 1327200503 1323300233 1410600153 1323300043 1327200513 1327200793 1411403473  1131902043 1328301563 1314908553  1132104893 1405701193 1315004953  1132104913 1407105423 1400802183  1426708823 1422701313 1400802193  1426708913 1200517413 1403605973  1413202093 1220102783 1403605993  1229300363 1221503073 1307802023  1230306343 1331708343 1419014663  1230306503 1331708413 1434400853  1234701653 1409000143 1434401073  1501309733 1409000183 1434401083  1217705053 1326305483 1413301453  1217705063 1326902363 1227520063  1305900263 1326902373 1312903303  1225601423 1326902383 1312906633  1414202943 1327200613 1314100813  
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactKelly Jo Davis
269-323-7700
Manufacturer Reason
for Recall		The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.
FDA Determined
Cause 2		Software design
ActionStryker issued e-mail notices to distributors and reps on March 26, 2015 advising that all battery charges would receive a software update to provide a field correction for the upgrade to units to be able to track device usage data to Stryker as designed. There is no customer action required, the chargers will transmit a message to Stryker once the upgrade is complete. Please contact Kelly Jo Davis at 269-389-2921 with any questions.
Quantity in Commerce223 chargers
DistributionUS Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, MS, MT, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and the foreign country of: Canada
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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