Events

Rappel de Device Recall Reprocessed Endoscopic Trocars

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Sustainability Solutions.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71394
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1836-2015
  • Date de mise en oeuvre de l'événement
    2015-06-01
  • Date de publication de l'événement
    2015-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137637
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lot Codes for Model CTS02: 362394, 420607, 428114, 429863, 459230, 459592, 459597, 459960, 459990, 461060, 461694, 465212, 466767, 467172, 468490, 469533, 469538, 469539, 469540, 469955, 469956, 469963, 470140, 470614, 471021, 471067, 471079, 471092, 471102, 471109, 471126, 471131, 471135, 471895, 472125, 473040, 473260, 473293, 474004, 474015, 474035, 474324, 474338, 474340, 474476, 475171, 475465, 475617, 476151, 476173, 476200, 476259, 476272, 476277, 476989, 477306, 477315, 478318, 478338, 478339 478668, 479821, 479828, 480663, 480677, 480682, 480684, 481607, 481808, 481951, 481960, 481968, 483554, 483918, 483922, 483926, 483953, 483963 484011, 484027, 484032, 485218, 485511, 485557, 485567, 485591, 485622, 485656, 485660, 486107, 486138, 486143, 486209, 486253, 486800, 487210, 489255, 489651, 489704, 489738, 489745, 489957, 489958, 489962, 489979, 490076, 490086, 490864, 491163, 491256, 600325, 600929, 601012, 601925, 601982, 603277, 609051, 1786420, 1825271, 1891296, 2027905, 2163528, 2171826, 2175866, 2208579, 2222389, 2271560, 2279303, 2315316, 2954381, 2954628, 2954637, 2954778, 2957110, 2957134, 2958233, 2958246, 2969207, 2969426, 2969662, 2971689, 2972095, 2973798, 2974887, 2975148, 2975549, 2978669, 2978885, 2978892, 2980457, 2980834, 2983706, 2984021, 2984032, 2987284, 2987526, 2987896, 2989769, 2991263, 2993610, 2994626, 2995924, 2999738, 3002060, 3005909, 3018096, 3018650, 3020166, 3020757, 3021385, 3024073, 3026984, 3028690, 3028730, 3031396, 3031995, 3034204, 3037138, 3039352, 3040004, 3042988, 3043284, 3047352, 3047368, 3052859, 3054151, 3056633, 3056646, 3058219, 3059896, 3061761, 3065444, 3067448, 3070389, 3070391, 3072732, 3072745, 3075949, 3078655, 3081506, 3082044, 3083550, 3083597, 3085192, 3086485, 3086492, 3089009, 3091458, 3093279, 3096393, 3099949, 3184750, 3185474, 3186015, 3187181, 3187989, 3190002, 3190820, 3192550, 3193913, 3195683, 3198508, 3200845, 3201425, 3203415, 3204394, 3206304, 3207173, 3209437, 3210285, 3212965, 3214734, 3215952, 3217550, 3222005, 3224973, 3226077, 3231623, 3232298, 3234278, 3235296, 3286925, 3287266, 3290012, 3291855, 3291864  Lot Codes for Model CTS22: 362394, 365226, 419887, 429863, 459960, 469533, 469538, 469539, 469540, 471038, 471895, 472125, 475171, 476259, 481709, 481951, 481965, 481971, 483578, 483963, 484002, 484032, 485506, 486148, 486800, 487212, 487954, 489255, 489957, 490153, 603981, 1742132, 2171826, 2271563, 2295535, 3180274, 3180699, 3180702, 3185379, 3187970, 3190574, 3193160, 3195339, 3200866, 3209060, 3212544, 3215947, 3218572, 3221995, 3225575, 3226065, 3233621, 3288568, 3288575
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed Nationwide including Puerto Rico.
  • Description du dispositif
    Cannula and Seal; 5mm x 100mm and 12mm x 100mm || Model #: CTS02 and CTS22. || 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
  • Adresse du fabricant
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA