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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Endoscopic Trocars

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  Class 2 Device Recall Reprocessed Endoscopic Trocars see related information
Date Initiated by Firm June 01, 2015
Date Posted June 25, 2015
Recall Status1 Terminated 3 on August 16, 2016
Recall Number Z-1834-2015
Recall Event ID 71394
510(K)Number K063788  
Product Classification Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
Product 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.
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 
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
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.
Quantity in Commerce 147,351
Distribution Distributed Nationwide including Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NLM and Original Applicant = ASCENT HEALTHCARE SOLUTIONS
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