| Class 2 Device Recall Capless Li Pedicle Screw System | |
Date Initiated by Firm | March 24, 2009 |
Date Posted | August 19, 2009 |
Recall Status1 |
Terminated 3 on April 25, 2012 |
Recall Number | Z-1694-2009 |
Recall Event ID |
51956 |
510(K)Number | K072282 |
Product Classification |
Orthosis, spondyloisthesis spinal fixation - Product Code MNH
|
Product | Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile.
The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft. |
Code Information |
Product Numbers: 71088, 71692, 71708, 71750, 71761, 71781, 71807, 71849, 71881, 71090, 71693, 71709, 71751, 71762, 71787, 71808, 71850, 71882, 71092, 71694, 71710, 71752, 71763, 71789, 71809, 71851, 71885, 71682, 71695, 71711, 71753, 71764, 71791, 71810, 71857, 71886, 71686, 71696, 71712, 71755, 71765, 71793, 71811, 71858, 71889, 71687, 71698, 71716, 71756, 71766, 71795, 71813, 71859, 71893, 71688, 71700, 71746, 71757, 71767, 71797, 71814, 71873, 71894, 71689, 71701, 71747, 71758, 71768, 71799, 71815, 71874, 71896, 71690, 71705, 71748, 71759, 71769, 71801, 71816, 71877, 71897, 71691, 71707, 71749, 71760, 71780, 71806, 71817, 71878, 71899, 71900, 71937, 71957, 73417, 73427, 73440, 73453, 73470, 74073, 71903, 71939, 72184, 73418, 73428, 73441, 73454, 73471, 74097, 71904, 71940, 72419, 73419, 73429, 73445, 73455, 73472, 74098, 71907, 71943, 73409, 73420, 73430, 73446, 73456, 73760, 74099, 71908, 71944, 73411, 73421, 73431, 73447, 73464, 73761, 74100, 71911, 71947, 73412, 73422, 73433, 73448, 73465, 73762, 74101, 71912, 71948, 73413, 73423, 73435, 73449, 73466, 73763, 74102, 71915, 71952, 73414, 73424, 73437, 73450, 73467, 73886, 74103, 71916, 71953, 73415, 73425, 73438, 73451, 73468, 74047, 74104, 71936, 71956, 73416, 73426, 73439, 73452, 73469, 74072, 74105, 74107, 74125, 74143, 74293, 74305, 75280, 75297, 75307, 75317, 74108, 74127, 74144, 74294, 74306, 75282, 75299, 75308, 75318, 74109, 74129, 74285, 74295, 74307, 75283, 75300, 75309, 75319, 74110, 74131, 74286, 74296, 74432, 75284, 75301, 75310, 75320, 74111, 74132, 74287, 74299, 74987, 75285, 75302, 75311, 75321, 74112, 74134, 74288, 74300, 74991, 75287, 75303, 75312, 75322, 74116, 74135, 74289, 74301, 75248, 75289, 75304, 75313, 75323, 74119, 74137, 74290, 74302, 75273, 75291, 75305, 75314, 75324, 74121, 74139, 74291, 74303, 75276, 75293, 75305, 75315, 75333, 74123, 74141, 74292, 74304, 75278, 75295, 75306, 75316, 75334, 75335, 75355, 75376, 76369, 76536, 76593, 76602, 76613, 76639, 75336, 75358, 75377, 76370, 76537, 76593, 76603, 76614, 76640, 75337, 75360, 75379, 76372, 76538, 76594, 76605, 76615, 76642, 75338, 75362, 75382, 76374, 76540, 76595, 76606, 76616, 76737, 75344, 75364, 75384, 76375, 76542, 76596, 76607, 76618, 77253, 75346, 75365, 75386, 76376, 76588, 76597, 76608, 76619, 77260, 75346, 75367, 75588, 76377, 76589, 76598, 76609, 76621, 77261, 75350, 75370, 75798, 76406, 76590, 76599, 76610, 76629, 77262, 75351, 75372, 75802, 76407, 76591, 76600, 76611, 76630, 77263, 75353, 75375, 76139, 76534, 76592, 76601, 76612, 76638, 77264, 77265, 77811, 77852, 79382, 77266, 77815, 78174, 77267, 77817, 78175, 77270, 77820, 78176, 77322, 77823, 78518, 77647, 77851 and 79040. |
Recalling Firm/ Manufacturer |
X Spine Systems Inc 452 Alexandersville Rd Miamisburg OH 45342-3658
|
For Additional Information Contact | Eric Badders 937-847-8400 |
Manufacturer Reason for Recall | A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized). |
FDA Determined Cause 2 | Process control |
Action | X Spine Systems Inc. issued advisory notices in March 2009 to Consignees notifying them of the problem and requesting all affected product be returned to the firm. The firm also conducted telephone calls and emails for the return of the product.
For further information, contact X Spine Systems Inc. at 1-937-847-8400 extension 115. |
Quantity in Commerce | 9,613 units |
Distribution | Worldwide Distribution -- Including states of AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT and WY and countries of Spain, South Africa and the United Kingdom. |
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 = MNH
|
|
|
|