Devices

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
    Orthopedic Devices
  • 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
    Stryker Howmedica Osteonics Corp.
  • 1 Event

Manufacturer

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

499 devices with a similar name

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Device Recall Stryker Wire Caddy
  • Model / Serial
    Lots 10306012, 10323012, 10340022, 11007012 and 11047012
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.
  • Product Description
    Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210. || This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation
Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE
  • Model / Serial
    Lot number 10265CG2, Part number 5290-744-100
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
  • Product Description
    Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY || For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation
Device Recall Stryker Evacuation Chair
  • Model / Serial
    Model 6254, Lot numbers 110143822, 110143823, 110143824, 110143825, 110143826, 110143827, 101240120, 101240121, 101240122, 110142843, 110143758, 101240123, 101240124, 101240125, 101240126, 101240441, 101240442, 101240443, 101240863, 110142646, 110142632, 110142619, 110143756, 101240880, 110143801, 101240850, 101240851, 101240852, 101240853, 101240854, 101240855, 110143828, 110143829, 110143830, 110143831, 101241171, 101240127, 101240128, 101240129, 101240130, 101240131, 101240868, 101240892, 101240893, 101240894, 101240895, 101240896, 101240897, 101240898, 101240119, 110142620, 110143282, 110143283, 110143284, 110143281, 101240132, 101240133, 101240134, 101240135, 101240136, 101240137, 101240138, 101240139, 101240140, 101240141, 101240142, 101240143, 101240144, 101240858, 101240859, 101240860, 101240861, 101240862, 110143753, 110143754, 110143755, 101239046, 101239047, 101239048, 110142616, 110142617, 110142618, 101240145, 101240146, 110142625, 101241172, 101241173, 101241174, 101241175, 101241176, 101241177, 110142624, 101240870, 110142652, 110142653, 110142648, 110142649, 110142650, 110142651, 101241444, 101241445, 101241446, 101241447, 101241448, 101241449, 101240437, 101240438, 101240439, 101240440, 101241863, 101241864, 101241865, 101241866, 101240864, 101240865, 101240866, 101240867, 110142647, 110143222, 110142633, 110142634, 110142844, 110142621, 101240100, 101240101, 101240102, 101240103, 101240104, 101240105, 101240106, 101240107, 101240108, 101240109, 101240110, 101240111, 101240112, 101240113, 101240114, 101240881, 101240882, 101240883, 101240884, 110143832, 110143835, 110143797, 110143798, 110143799, 110143800, 110143750, 110143751, 110143757, 101240869, 110143802, 110143803, 110143804, 110143793, 110143794, 110143795, 110142630, 110142631, 101239030, 101239031, 101239032, 101239033, 101239034, 101239035, 101239036, 101239037, 101239038, 101239039, 101239040, 101239041, 101239042, 101239043, 101239044, 101239045, 101240416, 101240417, 101240418, 101240419, 101240420, 101240421, 101240422, 101240423, 101240424, 101240425, 101240426, 101240427, 101240428, 101240429, 101240430 01240431, 101240432, 101240433, 101240434, 101240435, 101241170, 101241152, 101240838, 101240839, 101240840, 101240841, 101240842, 101240843, 101240844, 101240845, 101240846, 101240408, 110143796, 101240118, 110142840, 110142841, 110142842, 101240409, 101240410, 101240411, 101240412, 101240413, 101240414 and 101240415.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
  • Product Description
    Stryker Evacuation Chair Model 6254 || It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation
Device Recall Stryker EMS Stair Pro Evacuation Chair
  • Model / Serial
    Model 6252, Lot numbers 110142628, 110142635, 101240404, 110143805, 101240405,110142848, 110143293, 110142846, 110142847, 110142849, 110142850, 110142851, 110142830, 110142887, 110142898, 110143270, 110143752, 110142828, 110142637, 110142826, 110142827, 110143299, 101240406, 101240447, 110143816, 101241853, 101241854, 101241855, 110143261, 110142607, 110142608, 110142609, 101240117, 101241850, 101241851, 101241188, 101240147, 101240148, 110142601, 110142602, 110142636, 110142863, 101240998, 101240999, 101241000, 101241001, 101241002, 101241003, 101241004, 101241005, 101241006, 101241007, 101241008, 101240436, 101240804, 101240805, 101240806, 101240871, 101241857, 101240115, 110143285, 110143286, 110142864, 101241856, 110142612, 110142654, 110142655, 110142656, 110142657, 110142658, 110142659, 110142660, 110142661, 110142662, 110142663, 110142664, 110142626, 110142627, 110142838, 110142839, 101240407, 101241862, 110142800, 110142801, 110143253, 110143294, 110142603, 110142886, 110143761, 101241125, 110142605, 110142832, 110142833, 110142834, 110142835, 110142836, 101240886, 110142629, 101240116, 110143289, 110142831, 101240403, 101240401, 110142610, 110142611, 110143762, 110143290, 110143820, 110143821, 101241127, 110142600, 110143836, 110142837, 101240885, 101240445, 101241199, 101240874, 101240875, 101240876, 101240877, 101240878, 101240879, 110143292, 110142606, 110143844, 110143845, 110143846, 110143847, 101241190, 101240873, 110142640, 110143287, 101240444, 110142825, 101241858, 101241859, 110142899, 101240402, 101241852, 110142845, 110142644, 110142645, 110143295, 110143848, 101240872, 101240887, 101240888, 101240889, 101240890, 101240891, 110143817, 110143818, 110143819, 110143245, 110143246, 110143247, 110143248, 110143249, 110143806, 110143807, 110143808, 110143809, 110143810, 110142885, 110143768, 110143769, 110143770, 110143771, 110143772, 110143773, 110143774, 110143775, 110143776, 110143777, 110143778, 110143779, 110143780, 110143781, 110143782, 110143783, 110143784, 110143785, 110143786, 110143787, 110143788, 110143789, 110143790, 110143791, 110143792, 101241189, 110143837, 110143838, 101241111, 101241112, 110143298, 110142639, 101241860, 101241861, 110142803, 101241187, 110142614, 110143296, 110142643, 101241114, 101241115, 110142829, 110143759, 110143760, 101240446, 101240899, 110142641, 110142642, 101240448 and 110143288.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
  • Product Description
    Stryker EMS Stair - Pro Evacuation Chair Model 6252 || It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation
Device Recall Stryker Medical 1037 Trauma
  • Model / Serial
    Lots 1104030100, 1104030101, 1104030102, 1104030103, 1104030023 and 1104030024.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, CA, FL, GA, HI, IL, MA, MN, MO, NH, NJ, NV, NY, PA, RI, TX, UT, and VA and the country of THE NETHERLANDS.
  • Product Description
    Stryker Medical Stretcher Model 1037 Trauma || A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation
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