I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information: 1. Article Number (Lot Numbers): 31404-16 (679/062339, 679/122213, 679/122332), 31404-18 (679/122212, 679/062340), 31404-20 (18/089221, 679/062343, 679/122241), 31404-22 (18/061535, 679/012416, 679/062350), 31404-24 (18/071536, 679/062362, 679/122246), 31404-26 (679/122245, 679/062363), 31404-28 (18/186278, 679/062364), 31404-30 (18/187299, 679/012401, 679/062365, 679/122242), 31404-32 (18/111540, 679/062366, 679/122211), 31404-34 (679/122206, 18/121544, 679/012402, 679/042414, 679/072302, 679/122206), 31404-36 (18/188300, 679/052403, 679/072305, 679/112223), 31404-38 (18/189301, 679/112213, 679/012455, 679/072309), 31404-40 (18/181043, 679/062321, 679/122201, 679/122310, 679/052404, 679/032532), 31404-42 (679/122203, 18/191303, 679/072310, 679/012418, 679/052424, 679/052505), 31404-44 (18/192304, 679/112232, 679/052332, 679/052425, 679/052508), 31404-46 (679/122240, 679/062322, 679/112210, 679/052426, 679/042505), 31404-48 (679/052427, 679/072317, 679/122248), 31404-50 (18/194306, 679/112228, 679/062301, 679/122311, 679/052406, 679/052413, 679/042506, 679/062501), 31404-55 (18/195307, 679/122258, 18/211647, 679/072326, 679/012452, 679/062467, 679/062511), 31404-60 (18/196308, 679/112240, 679/052325, 679/122312, 679/062485, 679/062512), 31404-65 (679/122259, 679/072327, 18/205310, 679/022410), 31404-70 (679/012301, 18/197309, 679/072328, 679/022413, 679/062479), 31404-75 (18/205411, 18/381989, 679/012302), 31404-80 (18/172638, 18/205232, 18/321164, 679/022416), 31457-30 (26/F50332), 31457-36 (18/198343), 31457-40 (18/199344), 31457-46 (18/947783, 18/736681), 31457-50 (18/201346, 26/F67796), 31457-55 (18/202347, 26/F67797), 31457-60 (18/203355), 31652-100 (679/122117, 679/022350, 679/102335, 679/022335, 18/924999), 31652-105 (679/022336, 679/032377), 31652-110 (679/032380, 679/102339), 31652-115 (679/102336), 31652-120 (679/092002, 679/102347), 31652-25 (679/112134, 679/032340), 31652-30 (679/032341), 31652-35 (679/082315), 31652-40 (679/082316), 31652-45 (679/032330, 679/092332), 31652-55 (679/032391, 679/092333), 31652-60 (679/022337, 679/032378, 679/092336), 31652-65 (679/022338, 679/032322, 679/092347), 31652-70 (679/032320, 679/032365, 679/042405, 679/112154), 31652-75 (26/F65330, 679/032348, 679/032386), 31652-80 (679/112181, 679/032321, 679/092350, 679/032362, 679/092348, 679/042410, 18/920995), 31652-85 (679/122145, 679/032382, 679/022349, 679/102301, 679/102305, 679/042411, 18/541045), 31652-90 (679/012201, 679/032383, 679/032383, 679/022347, 679/042406), 31652-95 (18/923998, 679/012202, 679/032316), 31731-100 (18/775943, 26/F58803, 679/102420), 31731-105 (18/776944, 26/F58804, 26/F65649, 679/102421), 31731-110 (26/F58805, 26/F65650, 679/102422), 31731-115 (26/F58806, 26/F65651, 679/102423), 31731-120 (26/F58807, 26/F65652, 679/102436), 31731-50 (09/1244, 26/F14488, 26/F21185, 26/F58793), 31731-60 (26/F58795, 26/F65655), 31731-65 (26/F65656, 26/F58796), 31731-70 (26/F58797, 26/F65657), 31731-75 (26/F58798, 26/F65658), 31731-80 (679/072040, 26/F58799, 26/F65659), 31731-85 (18/331317, 26/F65660, 679/072044), 31731-90 (09/1247, 09/1248, 26/F58801, 26/F65661, 46/612), 31731-95 (18/581247, 26/F58802, 26/F65662, 679/102437), 31732-60 (18/961265), 31734-100 (26/F65672), 31734-105 (26/F58839, 26/F65673), 31734-110 (26/F58840, 26/F65674, 679/032425), 31734-115 (26/F65675), 31734-120 (26/F58842, 26/F65676, 26/F72277), 31734-45 (18/761192), 31734-50 (26/F58828, 26/F65680), 31734-60 (26/F58830), 31734-65 (26/F58831, 26/F65683, 679/032428), 31734-70 (26/F58832, 26/F65684, 26/F72275, 679/032429), 31734-75 (26/F58833, 26/F65685), 31734-80 (26/F58834, 26/F65686, 679/032435), 31734-85 (26/F58835, 26/F65687, 26/F72276), 31734-90 (26/F65688, 679/032436), 31734-95 (26/F58837, 26/F65689, 679/042401). 2. Article Number (Lot Numbers): 31277-18 (26/F36049), 31357-20 (18/091247), 31357-22 (679/031707), 31357-24 (86/485378), 31357-26 (18/121250), 31357-28 (26/F65909), 31357-30 (18/165201, 18/341054), 31357-32 (18/166217), 31357-34 (18/167218), 31357-36 (18/168219, 26/F65910), 31357-38 (18/167220), 31357-40 (26/F65911, 18/170221), 31357-42 (26/F65912), 31357-44 (18/171222, 18/361059, 26/F65913), 31357-46 (18/861060), 31357-48 (18/172223, 26/F65914), 31357-60 (26/F65648), 31357-65 (679/012125), 31357-70 (18/902013). 3. Article Number (Lot Numbers): 36851 (26/F59918, 26/F61351, 26/F64885, 26/F64886, 26/F65908, 26/F66506, 26/F71413, 26/F71764, 26/F72364, 26/F73020, 26/F74288). 4. Article Number (Lot Numbers): 36432 (26/F65379, 26/F67799, 26/F72744, 774/300002), 36653 (26/F62590, 26/F68455), 36732 (26/F67800). 5. Article Number (Lot Numbers): 36431 (26/F62589, 26/F65378, 26/F66505, 26/F67798, 26/F70092, 26/F72743, 26/F73017, 26/F73494), 36651 (26/F61694, 26/F65380, 26/F68454, 26/F73018), 36653 (26/F73019), 36731 (26/F60987, 26/F62591, 26/F67523, 26/F70093, 26/F72363, 26/F73495).

Distribution pattern: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.