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.
This recall has been terminated (originally issued August 19, 2009).
- Company
- X Spine Systems Inc
- Recall Initiated
- March 24, 2009
- Posted
- August 19, 2009
- Terminated
- April 25, 2012
- Recall Number
- Z-1694-2009
- Quantity
- 9,613 units
- Firm Location
- Miamisburg, OH
- Official Source
- View on FDA website ↗
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).
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.