Stryker

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

Orthopedic Devices

1

No

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

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.

Catalog #5901-S-4818, Lot MAC7C14.

Orthopedic Devices

2

Yes

US Nationwide

ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. || Howmedica Osteonics Corp. || A Subsidiary of Stryker Corp. || Stryker France || Non-sterile || Made in Cork Ireland

0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012

General Hospital and Personal Use Devices

2

No

Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

Stryker Model Number: 0904-410-000; Lot# 61406001

Gastroenterology-Urology Devices

2

No

US Nationwide Distribution in the states of: TX, NJ and MS.

Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM || Product Usage: || The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.

Catalog Number 5532-G-511 Lot LD8D7Y  Catalog Number 5537-G-319 Lot TT6JT2

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide

Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm || Product Usage: || The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.