Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. 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.
Enforcement
- Recall Number
- Z-1835-2015
- Event ID
- 71394
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 1, 2015
- Initiation Date
- June 1, 2015
- Classification Date
- June 25, 2015
- Termination Date
- August 16, 2016
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327, United States
Description
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. 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.
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.
Lot Codes for Model CTR03: 403486, 421850, 423482, 423498, 424916 459230, 459967, 459990, 460697, 462208, 465157, 465212, 470140, 471013, 471021, 471022, 471031, 471046, 471048, 471060, 471102, 471109, 471120 472125, 473260, 473295, 475478, 475488, 477315, 477866, 477886, 478318, 478338, 479079, 479670, 479673, 479821, 479828, 480465, 481745, 484011, 485511, 485557, 485567, 485591, 485622, 485656, 485660, 485669, 486112, 486138, 486142, 486150, 489568, 489957, 489962, 489979, 490076, 490086, 490088, 490758, 1992710, 1993479, 1997304, 1997315, 2000830, 2013237, 2014811, 2026372, 2026386, 2026408, 2035129, 2035138, 2035851, 2039108, 2039112 ,2047804, 2048945, 2049374, 2057081, 2060309, 2069618, 2070535, 2070588, 2071279, 2072131, 2100350, 2100378, 2111413, 2111421, 2114563, 2114585, 2114592, 2128288, 2128290, 2133045, 2134884, 2163528, 2175866, 2201534, 2201547, 2203131, 2203371, 2203562, 2208579, 2209452, 2209475, 2230529, 2232962, 2234218, 2236956, 2239309, 2241486, 2243783, 2244669, 2246728, 2248717, 2250745, 2252614, 2255994, 2259037, 2259059, 2261294, 2261304, 2261315, 2263727, 2263736, 2263743, 2265643, 2265658, 2265670, 2267530, 2267553, 2269653, 2269669, 2270325, 2271178, 2271184, 2275221, 2276869, 2282924, 2282948, 2284999, 2285029, 2287239, 2287241, 2288769, 2288776, 2290982, 2292454, 2292465, 2295737, 2295744, 2296614, 2297670, 2297691, 2299746, 2299751, 2300108, 2300120, 2315316, 2392083, 2392096, 2393026, 2393042, 2395363, 2395578, 2397485, 2397503, 2399456, 2399460, 2401371, 2401392, 2403422, 2406156, 2406160, 2407819, 2407826, 2409198, 2409200, 2485833, 2487715, 2489756, 2491428, 2493516, 2495477, 2497246, 2497251, 2499662, 2499670, 2499689, 2501927, 2501936, 2503726, 2503816, 2505908, 2505996, 2507620, 2507829, 2510016, 2510230, 2512012, 2512031, 2513625, 2587080, 2590965, 2603205, 2603214, 2603429, 2604554, 2604565, 2605022, 2605080, 2620626, 2621139, 2624943, 2628828, 2630134, 2632160, 2637735, 2642128, 2646037, 2647944, 2647971, 2648004, 2650432, 2650450, 2650715, 2652345, 2652378, 2652571, 2654365, 2654536, 2654543, 2659841, 2662099, 2708016, 2708997, 2710878, 2712010, 2713980, 2713998, 2717333, 2717720, 2718597, 2719039, 2719250, 2721394, 2721413, 2721510, 2723014, 2723067, 2723652, 2725429, 2725527, 2725706, 2727113, 2727355, 2727682, 2728922, 2728933, 2729512, 2729944, 2732547, 2732829, 2732838, 2734569, 2734595, 2735786, 2736154, 2736482, 2738317, 2739660, 2741664, 2744566, 2746216, 2746620, 2748498, 2749118, 2750852, 2754273, 2754826, 2755046, 2758292, 2759138, 2761771, 2762404, 2772543, 2775119, 2777153, 2777985 2781786, 2822857, 2823275, 2824051, 2824131, 2824149, 2824827, 2824993, 2826122, 2826360, 2826665, 2830363, 2830532, 2830675, 2830787, 2830889, 2831336, 2831646, 2831826, 2832542, 2832601, 2833466, 2833926, 2839788, 2841575, 2841581, 2842847, 2842984, 2845233, 2846463, 2848310, 2848709, 2851374, 2851480, 2853109, 2853338, 2855247, 2855473, 2856641, 2857180 2857198, 2858798, 2861778, 2861895, 2864786, 2874082, 2875168, 2879999, 2884054, 2884582, 2904497, 2904801, 2905958, 2906182, 2906406, 2908120,2908131, 2911611, 2911624, 2913130, 2913701, 2914205, 2924598, 2924918, 2924925, 2925373, 2934780, 2935038, 2935190, 2935933, 2935946, 2937667, 2937679, 2939581, 2939715, 2940225, 2940481, 2943258, 2943262, 2943386, 2944160, 2945439, 2945441, 2947200, 2947216, 2947974, 2950242, 2950411, 2950634, 2952923, 2953373, 2953704, 2961910, 2962343, 2963500, 2963516, 2963603, 2963851, 2965844, 2966122, 2966608, 2967100, 2967116, 2968697, 2969765, 2971322, 2973968, 2974054, 2975554, 2976098, 2977103, 2977119, 2977458, 2980913, 2981265, 2983775, 2983878, 2988228, 2988497, 2989384, 2989544, 2994027, 2994635, 2995969, 2996213, 2999900, 3006281, 3018106, 3020338, 3021862, 3024266, 3027013, 3027021, 3029259, 3032005, 3034215, 3055077, 3055181, 3057207, 3057211, 3059041, 3059369, 3062996, 3063009, 3066692, 3067647, 3067652, 3070857, 3070861, 3072895, 3072905, 3075954, 3076845, 3078896, 3079647, 3081872, 3082712, 3084776, 3084782, 3087477, 3087483, 3089874, 3089888, 3090834, 3092012, 3092451, 3093267, 3096109, 3098198, 3127329, 3128135, 3135738, 3149071, 3152970, 3152989, 3154423, 3162323, 3162914, 3165015, 3165299, 3168779, 3182561, 3211676, 3298040 Lot Codes for Model CTR73: 336923, 423482, 423498, 459996, 466789, 468474, 469956, 471031, 471048, 471060, 471067, 471082, 471109, 471120, 471126, 471131, 471135, 471136, 472125, 473040, 476126, 476158, 476190, 479673, 482137, 482692, 485506, 485591, 486142, 486143, 486618, 489957, 490076, 490086, 490758, 1997327, 1997336, 2000848, 2001693, 2001705, 2026420, 2026431, 2035140, 2035155, 2035867, 2035908, 2039131, 2039149, 2042908, 2042912, 2043698, 2043701, 2043717, 2043738, 2046967, 2047815, 2047827, 2048966, 2049361, 2053014, 2054619, 2054635, 2054642, 2055144, 2055163, 2055171, 2055185, 2059651, 2059679, 2061398, 2063324, 2063348, 2102575, 2113203, 2113725, 2118323, 2118334, 2126577, 2148897, 2150757, 2150761, 2152781, 2167635, 2175866, 2226267, 2228400, 2230834, 2237073, 2239345, 2241591, 2245133, 2245727, 2246700, 2246818, 2248729, 2250713, 2259490, 2261410, 2261423, 2267511, 2267524, 2269454, 2269477, 2271166, 2273985, 2275968, 2276876, 2279293, 2279326, 2281261, 2301842, 2301861, 2303568, 2303575, 2305295, 2306592, 2310470, 2312596, 2313332, 2313571, 2315316, 2324245, 2324250, 2334291, 2334317, 2340769, 2340782, 2343910, 2344414, 2344422, 2345370, 2345389, 2350222, 2350799, 2352624, 2354510, 2354523, 2354534, 2356343, 2356370, 2356389, 2359906, 2359910, 2361956, 2361960, 2476206, 2476949, 2476965, 2487727, 2487736, 2490685, 2491437, 2491444, 2492835, 2493954, 2494804, 2504932, 2506003, 2510248, 2565323, 2567468, 2581412, 2581431, 2582867, 2587219, 2592095, 2592122, 2593400, 2596634, 2598166, 2598624, 2606956, 2623923, 2660976, 2755033, 3170816, 3173582, 3175556, 3271913, 3285889
Distributed Nationwide including Puerto Rico.
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