Device Recall Stryker

  • Model / Serial
    Catalog No. 6541-4-808 Lot Nos.: SB1K14, SB1K14A, SB1K14A1, SB1K14P, SB1K15, SB1K15A, SB1K15A1, SB1K15A2, SB1M25, SB1M25A, SB1M25A1, SB1M25A2, SB1M25A2X1, SB1N02, SB1N02A, SB1N02A1, SB1N02A2, SB1N02A3, SB1N02X1, SB1T05, SB1T05A, SB1T05A1, SB1T05AX1, SB1T05AX2, SB1T05KSB1V01, SB1V01K, SB1V01L, SB1V01X1, SB1V01X2, SB1V01X3, SB1W14, SB1W14K, SB1W14X1, SB2T19, SB2T19A, SB2T19D, SB2T19DX1, SB2T19DX2, SB2T19J, SB2T19K, SB2T19KX1, SB2T19KX2, SBT19X3, SB2V87, SB2V87A, SB2V87J, SB2V87JX1, SB2V87K, SB2V87X, SB2V87X1, SB2W23, SB2W23G, SB2W23X, SB2W23X1, SB3A20, SB3A20A, SB3A21, SB3A21D, SB3A21M, SB3A21X, SB3A22, SB3A22A1, SB3A22X1, SB3A55, SB3A55A, SB3A55A2, SB3A55AX1, SB3A55M, SB3A55X1, SB3H25, SB3H25D, SB3H25G, SB3H25X1, SB3H26, SB3H26D, SB3H26DX1, SB3H26X2, SB3K09, SB3K09X1, SB3K10, SB3K10L, SB3K10M, SB3K10MX1, SB3K10X1, SB3L19, SB3L19D, SB3L19K, SB3L19L, SB3L19P, SB3L19P1, SB3L20, SB3L20K, SB3L45, SB3L45A, SB3L45A1, SB3L45A2, SB3L45D, SB3L45DX1, SB3L45L, SB3L45T, SB3M17, SB3M17A, SB3M17K, SB3M17M, SB3M18, SB3M18A, SB3M18AX1, SB3M18D, SB3M18M, SB3M18R, SB3M19, SB3M19A, SB3M19A1, SB3M19S, SB3M19T, SB3M19W, SB3N46, SB3N46D, SB3N46P, SB3N46X1, SB4C12, SB4C12X1, SB4C37, SB4C37X1, SB4C38, SB4C38A, SB4C38D, SB4E18, SB4E181, SB4E181X1, SB4E18A, SB4E18D, SB4E18T, SB4H79, SB4H79A, SB4H79M, SB4L05, SB4L05A, SB4N17, SB4N17E, SB4N17M, SB4N17M1, SB4N18, SB4N18A, SB4N18A1, SB4N18D, SB4N18M, SB4N18T, SB4S01, SB4S01D, SB4S01J, SB4V07, SB4V07L, SB4V07M, SB4V07MM, SB5A02, SB5A02A, SB5A02A1, SB5A55
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S || Product Usage: || Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

499 devices with a similar name

Learn more about the data here

  • Model / Serial
    510K 983382  Lot code 49073501
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NY, OH, PA, and TX.
  • Product Description
    Trident PSL HA Solid Back 50 mm || Includes Dome Hole Plug || Ref 540-11-50E || Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
  • Manufacturer
  • Model / Serial
    Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.
  • Product Description
    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
  • Manufacturer
  • Model / Serial
    ER5ND5 ER6EG4 ER5NE4 ER6EG5 ER5NE4M ER6EG5A ER6CG9 ER6KA1 ER6CG9A ER6KA2 ER6CH1 ER6KA3 ER6CH1A ER6KA3A ER6CH1D ER6KA3T ER6CH1M ER6KA4 ER6ED1 ER6KA5 ER6ED1A ER6KA6 ER6ED2 ER6KA7 ER6ED3 ER6KA7T ER6ED4 ER6KA8 ER6ED5 ER6KA8T ER6ED6 ER6KA9 ER6ED7 ER6KD1 ER6ED7E ER6KD2 ER6ED8 ER6KD3 ER6ED8J ER6KD4 ER6ED9 ER6KD5 ER6EE1Y ER6KD6 ER6EE2 ER6KD7 ER6EE6 ER6MA3 ER6EE6M ER6MA4 ER6EE7 ER6SA3 ER6EE7J ER6SA3J ER6EF2 ER6SA3X ER6EF3 ER6SA4 ER6EF3A ER7MA3 ER6EF4 ER7MA3D ER6EF4M ER7MA3M ER6EF5 ER7MA3T ER6EF6 ER7MA4 ER6EF6P ER7MA4A ER6EF8 ER7MA4E ER6EF9 ER7MA4T ER6EG2 ER8SK2 ER6EG3 ER8SK2M    ER8SK2P ER8SK3 ER8SK3X ER8SK4 ER8SK4A ER8SK4T ER8WA6 ER8WA6P ER8WA6X ER8WA9 ER8WA9A ER8WA9P ER9CH0 ER9CH0A ER9EA7
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.
  • Product Description
    Triathlon Distal Capture Assembly || Catalog No: 6541-1-723 || The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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
  • 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.
  • Manufacturer
  • Model / Serial
    Catalog #5901-S-4818, Lot MAC7C14.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide
  • Product Description
    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
  • Manufacturer
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