Device Recall Stryker

  • Model / Serial
    Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
  • Product Description
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. || Product Usage: || The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

499 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 10306012, 10323012, 10340022, 11007012 and 11047012
  • Product Classification
  • 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
  • Model / Serial
    Lot number 10265CG2, Part number 5290-744-100
  • Product Classification
  • 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
  • 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
  • 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
  • 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
  • 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
  • Model / Serial
    Lots 1104030100, 1104030101, 1104030102, 1104030103, 1104030023 and 1104030024.
  • Product Classification
  • 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
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