Device Recall Stryker

050115501, 050115502, 050115503, 050115504, 050115505, 050115506, 050115507, 050115508, 050115509, 050115510, 050115511, 050115512, 050115513, 050115514, 050115515, 050115516, 050115517, 050115518, 050115519, 050115520, 050115521, 050115522, 050115523, 050115524, 050115525, 050115526, 050115527, 050115528, 050115529, 050115530, 050115531, 050115532, 050115533, 050115534, 050115535, 050115536, 050115537, 050115538, 050115539, 050115942, 050215541, 050215542, 050215543, 050215544, 050215545, 050215546, 050315662, 050315663, 050315664, 050315665, 050315666, 050315667, 050315668, 050315669, 050315670, 050315671, 050315672, 050315673, 050315674, 050315675, 050315676, 050315677, 050315678, 050315679, 050315680, 050315681, 050315727, 050315728, 050315729, 050315730, 050315731, 050315732, 050315733, 050315734, 050315735, 050315736, 050315737, 050315738, 050315739, 050315740, 050315741, 050315742, 050315743, 050315744, 050315745, 050315746, 050516217, 050516218, 050516219, 050516220, 050516221, 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060315289, 060315290, 060315291, 060315292, 060315293, 060315294, 060315295, 060315296, 060315297, 060315298, 060315299, 060315300, 060315301, 060315302, 060315303, 060315304, 060315305, 060415198, 060415199, 060415200, 060415201, 060415202, 060415203, 060415204, 060415235, 060415236, 060516773, 060715976, 060715977, 060715978, 060715979, 060715980, 060715981, 060715982, 060715983, 060715984, 060715985, 060715986, 060715987, 060715988, 060715989, 060715990, 060715991, 060715992, 060715993, 060715994, 060715995, 060715996, 060715997, 060715998, 060715999, 060716000, 060816116, 060816249, 060816250, 060816251, 060816252, 060816253, 060816254, 060816255, 060915323, 060915324, 060915325, 060915326, 060915327, 060915328, 060915710, 060915711, 060915712, 060915713, 060915714, 060915715, 060915716, 060915717, 060915718, 060915844, 060915845, 060915846, 060915847, 060915848, 060915849, 060915850, 060915851, 060915852, 060915853, 061016343, 061215829, 061216220, 061216221, 061216222, 061216223, 061216224, 061216225, 061216226, 061216227, 061216228, 061216229, 061216230, 061216231, 061216232, 070116545, 070116546, 070116547, 070116548, 070116549, 070116550, 070116551, 070116552, 070116553, 070116554, 070116555, 070116556, 070116557, 070116558, 070116559, 070116560, 070215296, 070215297, 070315008, 070617739, 070617740, 070617741, 070617742, 070617743, 070617744, 070617745, 070617746, 070617747, 070617748, 070617749, 070617750, 070617751, 070617752, 070617753, 070617757, 070617758, 070617759, 070617760, 070617761, 070617762, 070617763, 070617764, 070617765, 070617766, 070617767, 070617768, 070617769, 070617770, 070617771, 070617772, 070617773, 070617774, 070617775, 070617776, 070715901, 070715902, 070715903, 070715904, 070715905, 070715906, 070715907, 070715908, 070715909, 070715910, 070715911, 070715912, 070715913, 070715914, 070715915, 070715916, 070715917, 070715918, 070715919, 070715920, 070715921, 070715922, 070715923, 070715924, 070715925, 070715926, 070715927, 070715928, 070715929, 070715930, 070715931, 070715932, 070715933, 070715934, 070715935, 070715936, 070715937, 070715938, 070715939, 070715940, 070715941, 070715942, 070715943, 070715944, 070715945, 070716001, 070716002, 070716003, 070716004, 070716005, 070716006, 070716007, 070716008, 070716009, 070716010, 070716011, 070716012, 070716013, 070717046, 070717047, 070717048, 070717049, 070717050, 070717051, 070717052, 070717053, 070717054, 070717055, 070717056, 070717057, 070717058, 070717059, 070717060, 070717061, 070717062, 070717063, 070717064, 070717065, 070717133, 070717134, 070717135, 070717136, 070717137, 070717138, 070717139, 070717140, 070717141, 070717142, 070717143, 070717144, 070717145, 070717146, 070717147, 070717148, 070717149, 070717150, 070717151, 070717152, 070717153, 070717154, 070717155, 070717156, 070717157, 070717583, 070717584, 070717585, 070717586, 070717587, 070717588, 070717589, 070815713, 070815714, 070815715, 070817146, 070817147, 070817148, 070817149, 070817150, 070817151, 070817152, 071016503, 071016504, 071016505, 071016506, 071016507, 071016508, 071016509, 071016510, 071016511, 071016512, 071016919.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.

Stryker Secure Model 3221, 230 V- 50/60 Hz, 500 lbs (227 Kg) || Stryker, Kalamazoo, MI 49001 || Product Usage: || Secure II (model 3221) Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units, but may also be found in a Critical Care environment. . Models 3221 represents International Voltage configurations of the 3002 model.

General Hospital and Personal Use Devices

2

No

Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.

GoBed+ . Model FL20E || Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.

Orthopedic Devices

1

No

Nationwide.

Stryker AVS Navigator Trials 6mm-15mm || Manufactured by: || Stryker Spine SAS || Z.1 Marticot-33610-Cestas -France || +33 (0) 5.57.97.06.30 || http;//www.stryker.com || Distributed in the USA by || Stryker Spine || 2 Pearl Court. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || Cestas France 33610. || Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.

General Hospital and Personal Use Devices

2

No

Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.

Go Bed II+ Model FL28C || Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

Model FL14E: Serial Number QB22371, QB22370, QB22369, QB22368, QB22367, QB21200, QB18330, QB17733, B22524, B22523, B22522, B22521, B22506, B22505, B22504, B22503, B22502, B22501, B22500, B22446, B22445, B22444, B22443, B22442, B22441, B22440, B22439, B22438, B22437, B22436, B22435, B22427, B22426, B22425, B22424, B22423, B22422, B22421, B22420, B22419, B22373, B22372, B22308, B22307, B22306, B22305, B22304, B22303, B22302, B22301, B22300, B22299, B22298, B22297, B22296, B22295, B22294, B22293, B22292, B22291, B22290, B22289, B22247, B22246, B22245, B22244, B22243, B22242, B22241, B22240, B22239, B22238, B22237, B22236, B22235, B22234, B22233, B22232, B22231, B22230, B22229, B22228, B22227, B22226, B22225, B22224, B22223, B22222, B22221, B22220, B22219, B22218, B22217, B22216, B22215, B22214, B22213, B22212, B22211, B22210, B22209, B22208, B22207, B22206, B22205, B22204, B22203, B22202, B22201, B22200, B22199, B22198, B22197, B22196, B22195, B22194, B22193, B22192, B22191, B22190, B22189, B22188, B22187, B22186, B22185, B22184, B22172, B22171, B22170, B22169, B22168, B22167, B22166, B22165, B22164, B22163, B22162, B22161, B22160, B22159, B22158, B22157, B22156, B22120, B22119, B22118, B22117, B22116, B22115, B22114, B22113, B22112, B22111, B22110, B22109, B22108, B22107, B22106, B22105, B22104, B22103, B22102, B22101, B22100, B22099, B22098, B22097, B22096, B22095, B22094, B22093, B22092, B22091, B22090, B22089, B22088, B22087, B22086, B22085, B22084, B22083, B22082, B22081, B22080, B22079, B22078, B22077, B22076, B22075, B22074, B22073, B22072, B22071, B22070, B22069, B22068, B22067, B22066, B22065, B22064, B22063, B22062, B22061, B22060, B22059, B22058, B22057, B22056, B22055, B22054, B22053, B22052, B22051, B22050, B22049, B22048, B22047, B22046, B22045, B22044, B22043, B22042, B22041, B22040, B22039, B22038, B22037, B22036, B22035, B22034, B22033, B22032, B22031, B22030, B22029, B22028, B22027, B22026, B22025, B22024, B22023, B22022, B22021, B22020, B22019, B22018, B22017, B22016, B22015, B22014, B22013, B22012, B21975, B21974, B21973, B21972, B21971, B21970, B21969, B21968, B21967, B21966, B21965, B21964, B21963, B21962, B21961, B21960, B21959, B21958, B21898, B21897, B21896, B21895, B21894, B21893, B21892, B21891, B21890, B21810, B21809, B21808, B21807, B21806, B21805, B21804, B21803, B21787, B21786, B21785, B21784, B21783, B21782, B21781, B21780, B21779, B21744, B21743, B21742, B21741, B21740, B21739, B21738, B21737, B21736, B21735, B21734, B21733, B21732, B21731, B21730, B21729, B21728, B21727, B21726, B21725, B21724, B21723, B21722, B21721, B21720, B21719, B21718, B21717, B21716, B21715, B21714, B21713, B21712, B21711, B21710, B21709, B21708, B21707, B21706, B21705, B21704, B21703, B21702, B21701, B21700, B21699, B21698, B21697, B21696, B21695, B21694, B21634, B21633, B21632, B21631, B21630, B21629, B21628, B21627, B21626, B21625, B21624, B21623, B21622, B21621, B21620, B21619, B21618, B21595, B21594, B21593, B21592, B21591, B21590, B21589, B21588, B21587, B21586, B21585, B21584, B21583, B21582, B21581, B21580, B21579, B21578, B21577, B21576, B21575, B21574, B21549, B21514, B21513, B21512, B21501, B21500, B21499, B21498, B21497, B21496, B21495, B21494, B21493, B21473, B21472, B21471, B21470, B21469, B21468, B21467, B21466, B21465, B21464, B21463, B21385, B21384, B21383, B21382, B21381, B21380, B21379, B21378, B21348, B21347, B21346, B21345, B21344, B21343, B21342, B21341, B21340, B21339, B21338, B21337, B21336, B21335, B21334, B21316, B21315, B21314, B21313, B21312, B21302, B21301, B21300, B21299, B21298, B21297, B21296, B21295, B21294, B21293, B21292, B21291, B21290, B21207, B21206, B21205, B21204, B21203, B21202, B21201, B21199, B21198, B21197, B21196, B21195, B21189, B21188, B21187, B21186, B21185, B21184, B21183, B21182, B21181, B21180, B21143, B21142, B21141, B21140, B21139, B21138, B21137, B21136, B21135, B21134, B21133, B21132, B21131, B21075, B21074, B21073, B21072, B21071, B21070, B20969, B20968, B20967, B20966, B20965, B20964, B20963, B20962, B20961, B20960, B20959, B20958, B20957, B20956, B20955, B20954, B20943, B20942, B20941, B20940, B20939, B20938, B20937, B20936, B20935, B20934, B20933, B20932, B20931, B20930, B20929, B20928, B20927, B20926, B20925, B20924, B20923, B20922, B20921, B20920, B20919, B20918, B20917, B20916, B20915, B20914, B20913, B20912, B20911, B20910, B20909, B20908, B20907, B20906, B20905, B20904, B20903, B20902, B20901, B20900, B20899, B20898, B20897, B20896, B20895, B20894, B20893, B20892, B20891, B20890, B20889, B20866, B20865, B20764, B20763, B20762, B20761, B20760, B20759, B20758, B20757, B20756, B20755, B20754, B20753, B20752, B20751, B20750, B20749, B20748, B20747, B20746, B20745, B20744, B20676, B20675, B20674, B20673, B20672, B20671, B20670, B20669, B20589, B20588, B20587, B20586, B20585, B20584, B20583, B20582, B20581, B20580, B20579, B20578, B20577, B20576, B20575, B20513, B20512, B20511, B20465, B20444, B20443, B20442, B20441, B20440, B20439, B20438, B20437, B20436, B20435, B20434, B20266, B20265, B20264, B20263, B20184, B20183, B20182, B20181, B20180, B20179, B20178, B20177, B20176, B20175, B20174, B20173, B20172, B20171, B20170, B20169, B20168, B20167, B20166, B20165, B20002, B20001, B20000, B19999, B19998, B19997, B19996, B19995, B19994, B19993, B19992, B19991, B19591, B19590, B19589, B19588, B19587, B19586, B19585, B19584, B19583, B19431, B19430, B19429, B19428, B19427, B19426, B19425, B19424, B19302, B19301, B19300, B19299, B19298, B19297, B19296, B19295, B19294, B19293, B19292, B19291, B19290, B19289, B19288, B19287, B19286, B19285, B19284, B19283, B19282, B19281, B19280, B19279, B19278, B19277, B19276, B19275, B19274, B19273, B19272, B19271, B19270, B19269, B19268, B19267, B19266, B19265, B19264, B19263, B19262, B19261, B19260, B19259, B19258, B19257, B19256, B19255, B19254, B19253, B19252, B19251, B19250, B19249, B19248, B19247, B19246, B19245, B19244, B19243, B19242, B19241, B19240, B19239, B19238, B19237, B19236, B19235, B19234, B19233, B19232, B19231, B19230, B19125, B19124, B19123, B19122, B19121, B19120, B19119, B19118, B19117, B19116, B19115, B19114, B19113, B19112, B19111, B19110, B19109, B19108, B19107, B19106, B19105, B19104, B19103, B19102, B19101, B19100, B19099, B19098, B19097, B19096, B19066, B19065, B19064, B19063, B19062, B19061, B19060, B19059, B19058, B19057, B19056, B19055, B19054, B19053, B19052, B19051, B19050, B19049, B19048, B19047, B19046, B19045, B19044, B19043, B19042, B19041, B19040, B19039, B19038, B19037, B19036, B18984, B18983, B18982, B18981, B18980, B18978, B18977, B18976, B18975, B18974, B18952, B18951, B18949, B18948, B18947, B18941, B18884, B18883, B18882, B18881, B18880, B18879, B18878, B18877, B18876, B18875, B18874, B18873, B18872, B18835, B18834, B18833, B18832, B18831, B18830, B18829, B18828, B18827, B18826, B18825, B18824, B18823, B18822, B18821, B18820, B18819, B18706, B18705, B18704, B18703, B18702, B18701, B18700, B18699, B18698, B18697, B18696, B18695, B18694, B18693, B18692, B18691, B18690, B18689, B18688, B18687, B18686, B18685, B18684, B18683, B18670, B18669, B18668, B18667, B18666, B18575, B18574, B18573, B18561, B18560, B18488, B18487, B18486, B18485, B18484, B18483, B18482, B18481, B18480, B18479, B18478, B18477, B18476, B18475, B18474, B18331, B18205, B18204, B18203, B18202, B17830, B17829, B17824, B17759, B17739, B17738, B17737, B17736, B17735, B17734, B17683, B17682, B17681, B17680, B17679, B17678, B17677, B17676, B17675, B17616, B17615, B17614, B17613, B17612, B17611, B17610, B17461, B17334, B17333, B17332, B17331, B17330, B17295, B17294, B17293, B17292, B17179, B17178, B17177, B16999, B16998, B16997, B16996, B16995, B16994, B16934, B16933, B16932, B16931, B16731, B16730, B16729, B16728, B16727, B16726, B16725, B16724, B16723, B16702, B16701, B16700, B16699, B16698, B16697, B16696, B16695, B16694, B16693, B16692, B16691, B16690, B16689, B16682, B16641, B16640, B16639, B16638, B16637, B16341, B16340, B16339, B16338, B16015, B16014, B16013, B16012, B16011, and B16010

General Hospital and Personal Use Devices

2

No

Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.

Stryker Rose Bed Model (FL14E) || Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone