Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be...
FDA Device Recall #Z-1587-2015 — Class III — March 25, 2015
Recall Summary
| Recall Number | Z-1587-2015 |
| Classification | Class III — Low risk |
| Date Initiated | March 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Instruments Div. of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 223 chargers |
Product Description
Universal 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.
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.
Distribution Pattern
US 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
Lot / 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
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Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.