Z-1835-2015Class II

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish...

Name: Z-1835-2015 Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish...
Creator: Stryker Sustainability Solutions
Published: 2015-06-01
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2015-06-01 / Terminated

FDA source

Stryker Sustainability Solutions began a recall of 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... on 2015-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1835-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-01
Posted: 2015-06-25
Terminated: 2016-08-16
Recalling firm: Stryker Sustainability Solutions
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.
Product code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
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 root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1835-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1834-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25
Z-1835-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25
Z-1836-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code NLM

K063788Class IIReprocessed Endoscopic Trocars and CannulasAscent Healthcare Solutions / cleared 2007-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)