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Recall Observatory FDA recall evidence

Device product

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.

Z-1835-2015

June 01, 2015

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 71394
Status
Terminated
Classification
Class II
Quantity
147,351
Official record key
device-enforcement:Z-1835-2015

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Distributed Nationwide including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.