Events

Device Recall Reprocessed Endoscopic Trocars 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Sustainability Solutions 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71394
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1834-2015
  • 사례 시작날짜
    2015-06-01
  • 사례 출판 날짜
    2015-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137620
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
  • 원인
    Stryker sustainability solutions is recalling trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
  • 조치
    On 06/01/15 a customer notification letter was sent out by the firm. The notification letter instructs customers to stop using the affected lots of the recalled product, and should consider other trocar models reprocesses by Stryker as an alternative. The letter notes that attached is a Effectiveness Check Form and complete list of affected lots shipped to the facility. A Stryker Sustainability Solutions Sales Representative will be sent to check the inventory of the affected lots. Once the inventory is checked the affected lots will be removed. The firm will complete a Recall Effectiveness Check Form . The form is to be completed even if no affected product is found. The firm requests that the form be returned to the sales representative or fax to 480-809-4975. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. The firm states that adverse reactions or quality problems experiences with the use of the product may be reported to the firm's hotline 888-888-3433 x5572, or at www.stryker.com/productexperience as well as through FDA's MedWatch Adverse Event Reporting program.

Device

Device Recall Reprocessed Endoscopic Trocars
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes for Model CTF03: 314326, 362394, 365229, 401076, 413450, 420581, 420607, 420609, 428106, 428114, 429863, 429866, 456224, 456242, 459592, 459597, 459617, 459954, 461862, 464282, 466767, 467197, 467198, 467350, 467413, 468306, 468471, 468497, 468498, 468941, 469533, 469538, 469539, 469956, 469960, 470614, 471039, 471048, 471060, 471126, 471721, 471725, 471789, 471895, 471911, 471917, 473040, 473280, 473936, 474004, 474035, 474061, 474338, 474340, 474381, 474482, 474487, 474493, 474940, 475171, 475429, 475439, 476151, 476152, 476155, 476191, 476200, 476259, 476277, 476751, 476985, 476989, 477172, 477304, 477306, 477865, 478264, 478268, 478668, 479437, 479821, 480663, 480684, 481109, 481615, 481808, 481951, 481968, 481977, 482137, 482216, 482607, 482630, 482664, 482669, 482672, 482692, 482885, 482956, 482959, 483508, 483554, 483908, 483911, 483918, 483953, 483963, 485020, 485218, 485502, 485581, 485671, 485724, 486058, 486143, 486209, 486394, 486800, 486853, 486855, 487203, 488297, 488356, 488601, 489255, 489701, 489717, 489745, 489960, 490084, 490101, 490864, 490887, 491256, 491267, 491500, 600329, 600462, 600929, 601012, 601786, 601925, 601945, 602261, 1700377, 1742132, 1750017, 1752379, 1825271, 1831415, 1838630, 1854074, 1873579, 1924143, 1940389, 1993186, 1995046, 2026174, 2027905, 2099505, 2128128, 2141295, 2171826, 2175866, 2201812,  2202067, 2207903, 2222389, 2256944, 2279303, 2958995, 2959099, 2959393, 2967775, 2967953, 2967969, 2968684, 2971490, 2972179, 2972432, 2972523, 2974255, 2974595, 2974645, 2974873, 2976787, 2977905, 2978075, 2978215, 2979090, 2979438, 2980071, 2980305, 2983205, 2983527, 2985634, 2985741, 2985993, 2986317, 2986329, 2987002, 2989753, 2989851, 2990255, 2990970, 2991547, 2991801, 2994252, 2994268, 2996250, 2996278, 2998784, 3000843, 3003011, 3003146, 3003534, 3006299, 3006309, 3007744, 3017809, 3017897, 3019141, 3020340, 3020726, 3021288, 3022515, 3022527, 3025882, 3032891, 3032917, 3033615, 3033627, 3035146, 3035151, 3035575, 3035581, 3052047, 3052863, 3053399, 3053458, 3059535, 3059906, 3063793, 3064331, 3064527, 3065459, 3065519, 3069524, 3074847, 3074852, 3075234, 3075247, 3076850, 3078395, 3078400, 3079634, 3080357, 3080361, 3080763, 3081497, 3083566, 3089890, 3089900, 3092020, 3092255, 3092264, 3093953, 3094667, 3094985, 3094992, 3095005, 3095014, 3099954, 3099965, 3100547, 3102846, 3102851, 3103176, 3103343, 3103358, 3108380, 3110878, 3111384, 3111795, 3113296, 3114007, 3114011, 3115286, 3116045, 3116050, 3118392, 3118407, 3120168, 3120650, 3120716, 3122269, 3122276, 3126999, 3127514, 3129755, 3133588, 3135549, 3138676, 3138682, 3141395, 3142937, 3145355, 3145364, 3149085, 3149658, 3152031, 3152110, 3154888, 3156973, 3160045, 3161763, 3162732, 3165164, 3165571, 3168278, 3168767, 3170546, 3170551, 3172878, 3172884, 3175161, 3175541, 3183829, 3185529, 3188163, 3190831, 3194023, 3198793, 3201657, 3203692, 3206793, 3209459, 3213698, 3216157, 3219175, 3223419, 3227058, 3229265, 3231929, 3242541, 3242556, 3242692, 3251050, 3251066, 3251078, 3253575, 3253581, 3257175, 3257524, 3258813, 3262050, 3262499, 3265301, 3266817, 3267267, 3267280, 3267527, 3269037, 3269085, 3270954, 3271670, 3275447, 3275452, 3278598, 3279897, 3282553, 3284583, 3284596, 3288082, 3288789, 3289234, 3290049   Lot Codes for CTF73: 3180165, 3181358, 3181959, 3183394, 3183432, 3185966, 3186537, 3188429, 3189243, 3192067, 3193604, 3194941, 3194994, 3198107, 3198239, 3201661, 3202726, 3204497, 3204506, 3207156, 3207160, 3210263, 3210271, 3214365, 3214377, 3217385, 3217407, 3220601, 3220849, 3224735, 3224742, 3227313, 3227321, 3229541, 3229556, 3231972, 3231986, 3233272, 3235415, 3235685, 3237169, 3237447, 3238117, 3238439, 3248221, 3274181, 3274524, 3274530, 3274936, 3275097, 3277283, 3277296, 3277502, 3277600,, 3278329, 3280207, 3280211, 3280224, 3291838
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide including Puerto Rico.
  • 제품 설명
    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. || Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • 제조사 주소
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA