FDAFDA · Food and drugs·Recall number Z-1836-2015
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.
Published July 1, 2015 · Recall initiated: June 1, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Sustainability Solutions
- Distributor
- Distributed Nationwide including Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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