Devices

Device Recall Stryker

  • 모델명 / 제조번호(시리얼번호)
    All serial/lot numbers
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide)
  • 제품 설명
    Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA || The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
  • Manufacturer
    Stryker Endoscopy
  • 1 Event

제조사

Stryker Endoscopy
  • 제조사 주소
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall Stryker Wire Caddy
  • 모델명 / 제조번호(시리얼번호)
    Lots 10306012, 10323012, 10340022, 11007012 and 11047012
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lot number 10265CG2, Part number 5290-744-100
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lots 1104030100, 1104030101, 1104030102, 1104030103, 1104030023 and 1104030024.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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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