Z-1834-2015 Class II Terminated
FDA device recall Z-1834-2015 was initiated by Stryker Sustainability Solutions on Jun 1, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Aug 16, 2016). Affected quantity: 147,351.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 1, 2015
- Initiation Date
- Jun 1, 2015
- Termination Date
- Aug 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147,351
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distributed Nationwide including Puerto Rico.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1834-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026