| | Class 2 Device Recall TRIGEN(R) INTERTAN(TM) NAIL |  |
| Date Initiated by Firm | July 02, 2014 |
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| Date Posted | August 17, 2014 |
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| Recall Status1 |
Terminated 3 on August 20, 2019 |
| Recall Number | Z-2258-2014 |
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| Recall Event ID |
68792 |
| 510(K)Number | K040212 |
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| Product Classification |
Nail, fixation, bone - Product Code JDS
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| Product | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL, 125o, REF 71675203, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 20 CM NAIL, 125o, REF 71675204, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM NAIL, 125o, REF 71675205, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 13MM X 20 CM NAIL, 125o, REF 71675206, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 130o, REF 71675207, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 130o, REF 71675208, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL, 130o, REF 71675209, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 20 CM NAIL, 130o, REF 71675210, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM NAIL, 130o, REF 71675211, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 13MM X 20 CM NAIL, 130o, REF 71675212, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 26 CM NAIL, 125o, LEFT, REF 71675213, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 32 CM NAIL, 125o, LEFT, REF 71675219, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 34 CM NAIL, 125o, LEFT, REF 71675221, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 34 CM NAIL, 125o, RIGHT, REF 71675222, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 36 CM NAIL, LEFT, 125o, REF 71675223, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 38 CM NAIL, 125o, LEFT, REF 71675225, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 40 CM NAIL, 125o, LEFT, REF 71675227, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 40 CM NAIL, 125o, RIGHT, REF 71675228, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 28 CM NAIL, 125o, RIGHT, REF 71675238, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 32 CM NAIL, 125o, LEFT, REF 71675241, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM NAIL, 125o, LEFT, REF 71675243, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM NAIL, 125o, RIGHT, REF 71675244, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM NAIL, 125o, LEFT, REF 71675245, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM NAIL, 125o, RIGHT, REF 71675246, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM NAIL, 125o, LEFT, REF 71675247, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM NAIL, 125o, RIGHT, REF 71675248, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM NAIL, 125o, LEFT, REF 71675249, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM NAIL, 125o, RIGHT, REF 71675250, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116
TRIGEN(R) INTERTAN(TM) 10MM X 26 CM NAIL, 130o, LEFT, REF 71675257, QTY (1), STERILE R, Smi |
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| Code Information |
TRIGEN INTERTAN 10MM X 18 CM NAIL, 125o, REF 71675201, Lot Numbers: 14CM05726, 14DM08712, 14CM12004, 14DM08713, 14CM12005, 14DM08714, 14CM12006, 14DM08715, 14CM12008, 14DM09828, 14CM12009, 14DM09829, 14CM15434, 14DM09830, 14CM15435, 14DM11951, 14CM15438, 14DM11952, 14CM15488, 14DM16264, 14CM15490, 14DM19617, 71675201 14CM17964, 14CM17965, 14CM17966, 14CM17966, 14DM01455, 14DM01456, 14DM04231, 14DM04232, 14DM04233, 14DM04234, 14DM04235, 14DM05411, 14DM05412, 71675201 14DM05413, 14DM05414, 14DM08711 TRIGEN INTERTAN 11.5MM X 18 CM NAIL, 125o, REF 71675202, Lot Numbers: 14CM15413, 14CM15415, 14CM15416, 14CM15417, 14CM15418, 14DM06190, 14DM06191, 14DM06192, 14DM06193, 14DM09835, 14DM09837 TRIGEN INTERTAN 13MM X 18 CM NAIL, 125o, REF 71675203, Lot Numbers: 14CM15443, 14CM01161, 14CM03675, 14CM05731, 14CM05732 TRIGEN INTERTAN 10MM X 20 CM NAIL, 125o, REF 71675204, Lot Numbers: 14CM15480 TRIGEN INTERTAN 11.5MM X 20 CM NAIL, 125o, REF 71675205, Lot Numbers: 14CM16786 TRIGEN INTERTAN 13MM X 20 CM NAIL, 125o, REF 71675206, Lot Numbers: 14CM03676, 14CM15471, 14CM16787 TRIGEN INTERTAN 10MM X 18 CM NAIL, 130o, REF 71675207, Lot Numbers: 14DM06197, 14DM08716, 14DM13210, 14DM13212 TRIGEN INTERTAN 11.5MM X 18 CM NAIL, 130o, REF 71675208, Lot Numbers: 14DM01460, 14DM01461, 14DM01462, 14DM01463, 14DM01464 TRIGEN INTERTAN 13MM X 18 CM NAIL, 130o, REF 71675209, Lot Numbers: 14CM15467, 14CM16788, 14CM16789, 14DM11044 TRIGEN INTERTAN 10MM X 20 CM NAIL, 130o, REF 71675210, Lot Numbers: 14CM15466, 14CM18995, 14CM18996, 14CM18997, 14CM18998, 14DM00764, 14DM00765, 14DM00766, 14DM00767 TRIGEN INTERTAN 11.5MM X 20 CM NAIL, 130o, REF 71675211, Lot Numbers: 14CM15464, 14CM18999, 14CM19000, 14CM21712, 14CM19001, 14CM21720, 14DM00769, 14DM00770 TRIGEN INTERTAN 13MM X 20 CM NAIL, 130o, REF 71675212, Lot Numbers: 14CM15463, 14CM16790 TRIGEN INTERTAN 10MM X 26 CM NAIL, 125o, LEFT, REF 71675213, Lot Numbers: 14DM14689 TRIGEN INTERTAN 10MM X 32 CM NAIL, 125o, LEFT, REF 71675219, Lot Numbers: 14DM17741 TRIGEN INTERTAN 10MM X 34 CM NAIL, 125o, LEFT, REF 71675221, Lot Numbers: 14DM08628 TRIGEN INTERTAN 10MM X 34 CM NAIL, 125o, RIGHT, REF 71675222, Lot Numbers: 14CM20693, 14DM16827 TRIGEN INTERTAN 10MM X 36 CM NAIL, LEFT, 125o, REF 71675223, Lot Numbers: 14CM19633 TRIGEN INTERTAN 10MM X 38 CM NAIL, 125o, LEFT, REF 71675225, Lot Numbers: 14CM17883, 14CM17884, 14CM17885, 14CM17886, 14DM04200, 14DM04201 TRIGEN INTERTAN 10MM X 40 CM NAIL, 125o, LEFT, REF 71675227, Lot Numbers: 14DM02910 TRIGEN INTERTAN 10MM X 40 CM NAIL, 125o, RIGHT, REF 71675228, Lot Numbers: 14DM11022 TRIGEN INTERTAN 11.5MM X 28 CM NAIL, 125o, RIGHT, REF 71675238, Lot Numbers: 14DM07429 TRIGEN INTERTAN 11.5MM X 32 CM NAIL, 125o, LEFT, REF 71675241, Lot Numbers: 14DM04202, 14CM10084 TRIGEN INTERTAN 11.5MM X 34 CM NAIL, 125o, LEFT, REF 71675243, Lot Numbers: 14CM21692 TRIGEN INTERTAN 11.5MM X 34 CM NAIL, 125o, RIGHT, REF 71675244, Lot Numbers: 14DM05253, 14DM05254 TRIGEN INTERTAN 11.5MM X 36 CM NAIL, 125o, LEFT, REF 71675245, Lot Numbers: 14DM14008 TRIGEN INTERTAN 11.5MM X 36 CM NAIL, 125o, RIGHT, REF 71675246, Lot Numbers: 14DM02912, 14DM14691 TRIGEN INTERTAN 11.5MM X 38 CM NAIL, 125o, LEFT, REF 71675247, Lot Numbers: 14DM05255 TRIGEN INTERTAN 11.5MM X 38 CM NAIL, 125o, RIGHT, REF 71675248, Lot Numbers: 14DM02913, 14DM02913, 14DM04204, 14DM04205 TRIGEN INTERTAN 11.5MM X 40 CM NAIL, 125o, LEFT, REF 71675249, Lot Numbers: 14DM07434, 14CM16262 TRIGEN INTERTAN 11.5MM X 40 CM NAIL, 125o, RIGHT, REF 71675250, Lot Numbers: 14DM11931 TRIGEN INTERTAN 10MM X 26 CM NAIL, 130o, LEFT, REF 71675257, Lot Numbers: 14CM14081 TRIGEN INTERTAN 10MM X 26 CM NAIL, 130o, RIGHT, REF 71675258, Lot Numbers: 14CM17967 TRIGEN INTERTAN 10MM X 30 CM NAIL, 130o, LEFT, REF 71675261, Lot Numbers: 14CM10088 TRIGEN INTERTAN 10MM X 30 CM NAIL, 130o, RIGHT, REF 71675262, Lot Numbers: 14CM15830 TRIGEN INTERTAN 10MM X 32 CM NAIL, 130o, LEFT, REF 71675263, Lot Numbers: 14CM18422, 14CM21682 TRIGEN INTERTAN 10MM X 32 CM NAIL, 130o, RIGHT, REF 71675264, Lot Numbers: 14CM15833, 14CM15834 TRIGEN INTERTAN 10MM X 34 CM NAIL, 130o, LEFT, REF 71675265, Lot Numbers: 14CM20698, 14CM20700, 14DM16204 TRIGEN INTERTAN 10MM X 34 CM NAIL, 130o, RIGHT, REF 71675266, Lot Numbers: 14CM15837, 14DM11023, 14DM11024, 14DM11025 TRIGEN INTERTAN 10MM X 36 CM NAIL, 130o, LEFT, REF 71675267, Lot Numbers: 14CM21686, 14DM03076, 14DM16823 TRIGEN INTERTAN 10MM X 36 CM NAIL, 130o, RIGHT, REF 71675268, Lot Numbers: 14CM15839, 14DM11932, 14DM11933 TRIGEN INTERTAN 10MM X 38 CM NAIL, 130o, LEFT, REF 71675269, Lot Numbers: 14CM10090 TRIGEN INTERTAN 10MM X 38 CM NAIL, 130o, RIGHT, REF 71675270, Lot Numbers: 14DM07441 TRIGEN INTERTAN 10MM X 40 CM NAIL, 130o, RIGHT, REF 71675272, Lot Numbers: 14CM10091 TRIGEN INTERTAN 10MM X 42 CM NAIL, 130o, LEFT, REF 71675273, Lot Numbers: 14CM10092 TRIGEN INTERTAN 11.5MM X 26 CM NAIL, 130o, LEFT, REF 71675279 Lot Numbers: 14DM08119 TRIGEN INTERTAN 11.5MM X 26 CM NAIL, 130o, RIGHT, REF 71675280 Lot Numbers: 14DM07383 TRIGEN INTERTAN 11.5MM X 28 CM NAIL, 130o, RIGHT, REF 71675282, Lot Numbers: 14DM07474 TRIGEN INTERTAN 11.5MM X 30 CM NAIL, 130o, RIGHT, REF 71675284, Lot Numbers: 14DM07480 TRIGEN INTERTAN 11.5MM X 32 CM NAIL, 130o, RIGHT, REF 71675286, Lot Numbers: 14DM07465, 14DM07468 TRIGEN INTERTAN 11.5MM X 34 CM NAIL, 130o, LEFT, REF 71675287, Lot Numbers: 14CM10093, 14DM07379 TRIGEN INTERTAN 11.5MM X 34 CM NAIL, 130o, RIGHT, REF 71675288, Lot Numbers: 14CM10094, 14DM07373 TRIGEN INTERTAN 11.5MM X 36 CM NAIL, 130o, RIGHT, REF 71675290, Lot Numbers: 14CM10095, 14DM07457 TRIGEN INTERTAN 11.5MM X 38 CM NAIL, 130o, LEFT, REF 71675291, Lot Numbers: 14CM09471 TRIGEN INTERTAN 11.5MM X 38 CM NAIL, 130o, RIGHT, REF 71675292, Lot Numbers: 14CM10097, 14DM13214 TRIGEN INTERTAN 11.5MM X 40 CM NAIL, 130o, RIGHTT, REF 71675294, Lot Numbers: 14DM07448 TRIGEN INTERTAN 10S 10MM X 18 CM NAIL, 125o, REF 71675383, Lot Numbers: 14CM08470, 14CM08471, 14CM08472, 14CM08473, 14CM08474, 14CM15447, 14CM15449, 14CM15451, 14CM20793, 14CM20799, 14DM02914, 14DM02917, 14DM02918, 14DM13216, 14DM13217, 14DM14696, 14DM14697, 14DM14698 TRIGEN INTERTAN 10S 10MM X 18 CM NAIL, 130o, REF 71675384, Lot Numbers: 14CM20800, 14CM20803, 14DM02919, 14DM02920, 14DM02921, 14DM04240, 14DM04241, 14DM05416 TRIGEN INTERTAN 10S 10MM X 20 CM NAIL, 125o, REF 71675385, Lot Numbers: 14DM19439 TRIGEN INTERTAN 13MM X 38 CM NAIL, 125o, LEFT, REF 71675413, Lot Numbers: 14CM16791 TRIGEN INTERTAN 1.5 10MM X 26 CM NAIL, 125o, LEFT, REF 71676501, Lot Numbers: 14CM17968 TRIGEN INTERTAN 1.5 10MM X 30 CM NAIL, 125o, RIGHT, REF 71676506, Lot Numbers: 14DM14702 TRIGEN INTERTAN 1.5 10MM X 34 CM NAIL, 125o, RIGHT, REF 71676510, Lot Numbers: 14CM10739 TRIGEN INTERTAN 1.5 10MM X 40 CM NAIL, 125o, LEFT, REF 71676515, Lot Numbers: 14CM10740 TRIGEN INTERTAN 1.5 10MM X 44 CM NAIL, 125o, RIGHT, REF 71676520, Lot Numbers: 14CM20366, 14DM16205 TRIGEN INTERTAN 1.5 10MM X 36 CM NAIL, 130o, RIGHT, REF 71676534, Lot Numbers: 14DM08632 TRIGEN INTERTAN 1.5 10MM X 38 CM NAIL, 130o, LEFT, REF 71676535, Lot Numbers: 14CM16762, 14CM16763 TRIGEN INTERTAN 1.5 10MM X 44 CM NAIL, 130o, LEFT, REF 71676541, Lot Numbers: 14CM19634 TRIGEN INTERTAN 1.5 11.5MM X 28 CM NAIL, 125o, LEFT, REF 71676547, Lot Numbers: 14DM01466 TRIGEN INTERTAN 1.5 11.5MM X 28 CM NAIL, 125o, RIGHT, REF 71676548, Lot Numbers: 14DM05257 TRIGEN INTERTAN 1.5 11.5MM X 30 CM NAIL, 125o, LEFT, REF 71676549, Lot Numbers: 14DM01467 TRIGEN INTERTAN 1.5 11.5MM X 30 CM NAIL, 125o, RIGHT, REF 71676550, Lot Numbers: 14DM01468 TRIGEN INTERTAN 1.5 11.5MM X 32 CM NAIL, 125o, RIGHT, REF 71676552, Lot Numbers: 14DM13198 TRIGEN INTERTAN 1.5 11.5MM X 34 CM NAIL, 125o, LEFT, REF 71676553, Lot Numbers: 14CM18424, 14DM14296, 14DM17751, 14DM17754 TRIGEN INTERTAN 1.5 11.5MM X 34 CM NAIL, 125o, RIGHT, REF 71676554, Lot Numbers: 14CM21694, 14DM01470 TRIGEN INTERTAN 1.5 11.5MM X 36 CM NAIL, 125o, LEFT, REF 71676555, Lot Numbers: 14CM21690, 14DM17740 TRIGEN INTERTAN 1.5 11.5MM X 36 CM NAIL, 125o, RIGHT, REF 71676556, Lot Numbers: 14CM05007, 14DM11026 TRIGEN INTERTAN 1.5 11.5MM X 38 CM NAIL, 125o, LEFT, REF 71676557, Lot Numbers: 14DM09815 TRIGEN INTERTAN 1.5 11.5MM X 38 CM NAIL, 125o, RIGHT, REF 71676558, Lot Numbers: 14DM02922, 14DM09816, 14DM09817 TRIGEN INTERTAN 1.5 11.5MM X 40 CM NAIL, 125o, LEFT, REF 71676559, Lot Numbers: 14DM09819 TRIGEN INTERTAN 1.5 11.5MM X 40 CM NAIL, 125o, RIGHT, REF 71676560, Lot Numbers: 14DM00771, 14DM00772, 14DM00773, 14DM00774, 14DM00775, 14DM00776, 14DM17748 TRIGEN INTERTAN 1.5 11.5MM X 42 CM NAIL, 125o, LEFT, REF 71676561, Lot Numbers: 14CM19696, 14CM19698, 14CM19699, 14CM19703 TRIGEN INTERTAN 1.5 11.5MM X 42 CM NAIL, 125o, RIGHT, REF 71676561, Lot Numbers: 14CM19703 TRIGEN INTERTAN 1.5 11.5MM X 44 CM NAIL, 125o, LEFT, REF 71676563, Lot Numbers: 14DM16824 TRIGEN INTERTAN 1.5 11.5MM X 44 CM NAIL, 125o, RIGHT, REF 71676564, Lot Numbers: 14CM20701, 14CM20703 TRIGEN INTERTAN 1.5 11.5MM X 46 CM NAIL, 125o, LEFT, REF 71676565, Lot Numbers: 14DM05259 TRIGEN INTERTAN 1.5 11.5MM X 26 CM NAIL, 130o, RIGHT, REF 71676568, Lot Numbers: 14CM20308 TRIGEN INTERTAN 1.5 11.5MM X 28 CM NAIL, 130o, RIGHT, REF 71676570, Lot Numbers: 14CM11204 TRIGEN INTERTAN 1.5 11.5MM X 30 CM NAIL, 130o, RIGHT, REF 71676572, Lot Numbers: 14DM06198 TRIGEN INTERTAN 1.5 11.5MM X 32 CM NAIL, 130o, LEFT, REF 71676573, Lot Numbers: 11JM10220B, 14CM20310, 14CM20311, 14DM06199 TRIGEN INTERTAN 1.5 11.5MM X 32 CM NAIL, 130o, RIGHT, REF 71676574, Lot Numbers: 14CM14066, 14DM06200, 14DM06202 TRIGEN INTERTAN 1.5 11.5MM X 34 CM NAIL, 130o, LEFT, REF 71676575, Lot Numbers: 11FM14740A, 14CM20312, 14CM20313, 14CM20315 TRIGEN INTERTAN 1.5 11.5MM X 34 CM NAIL, 130o, RIGHT, REF 71676576, Lot Numbers: 14CM19635, 14CM19636, 14DM06203 TRIGEN INTERTAN 1.5 11.5MM X 36 CM NAIL, 130o, LEFT, REF 71676577, Lot Numbers: 14CM17887 TRIGEN INTERTAN 1.5 11.5MM X 36 CM NAIL, 130o, RIGHT, REF 71676578, Lot Numbers: 14CM19637, 14CM19638 TRIGEN INTERTAN 1.5 11.5MM X 38 CM NAIL, 130o, LEFT, REF 71676579, Lot Numbers: 14CM14070, 14CM14071, 14CM14072, 14CM17970, 14DM13200, 14DM13202 TRIGEN INTERTAN 1.5 11.5MM X 38 CM NAIL, 130o, RIGHT, REF 71676580, Lot Numbers: 14CM14073, 14DM14011, 14CM14074 TRIGEN INTERTAN 1.5 11.5MM X 40 CM NAIL, 130o, LEFT, REF 71676581, Lot Numbers: 14CM20367, 14CM20368, 14DM11027 TRIGEN INTERTAN 1.5 11.5MM X 40 CM NAIL, 130o, RIGHT, REF 71676582, Lot Numbers: 14CM14077, 14CM14078, 14CM20369, 14CM20370, 14CM20371, 14CM20372 TRIGEN INTERTAN 1.5 11.5MM X 42 CM NAIL, 130o, LEFT, REF 71676583, Lot Numbers: 13JM17934, 14DM16822 TRIGEN INTERTAN 1.5 11.5MM X 42 CM NAIL, 130o, RIGHT, REF 71676584, Lot Numbers: 14DM06204, 14CM21734, 14CM21733 TRIGEN INTERTAN 1.5 11.5MM X 44 CM NAIL, 130o, LEFT, REF 71676585, Lot Numbers: 14DM07994 TRIGEN INTERTAN 1.5 13MM X 34 CM NAIL, 125o, LEFT, REF 71676597, Lot Numbers: 14DM02923 TRIGEN INTERTAN 1.5 13MM X 34 CM NAIL, 125o, RIGHT, REF 71676598, Lot Numbers: 14DM07995 TRIGEN INTERTAN 1.5 13MM X 38 CM NAIL, 125o, RIGHT, REF 71676602, Lot Numbers: 14DM08001, 14DM11954 TRIGEN INTERTAN 1.5 13MM X 40 CM NAIL, 125o, LEFT, REF 71676603, Lot Numbers: 14DM14038 TRIGEN INTERTAN 1.5 13MM X 42 CM NAIL, 125o, RIGHT, REF 71676606, Lot Numbers: 14CM16792 TRIGEN INTERTAN 1.5 13MM X 44 CM NAIL, 125o, RIGHT, REF 71676608, Lot Numbers: 14CM16793 TRIGEN INTERTAN 1.5 13MM X 32 CM NAIL, 130o, RIGHT, REF 71676618, Lot Numbers: 14CM16796 TRIGEN INTERTAN 1.5 13MM X 34 CM NAIL, 130o, RIGHT, REF 71676620, Lot Numbers: 14DM16271 TRIGEN INTERTAN 1.5 13MM X 36 CM NAIL, 130o, RIGHT, REF 71676622, Lot Numbers: 14CM01174 TRIGEN INTERTAN 10MM X 24 CM NAIL, 125o, REF 71934479, Lot Numbers: 14CM11765 TRIGEN INTERTAN 10MM X 24 CM NAIL, 130o, REF 71934480, Lot Numbers: 14CM11766 TRIGEN INTERTAN 11.5MM X 24 CM NAIL, 130o, REF 71934482, Lot Numbers: 14CM11768 |
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
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| For Additional Information Contact | Joe Metzger
978-749-1330 |
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Manufacturer Reason
for Recall | There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Smith & Nephew Issued an Urgent Product Recall dated July 2, 2014 to all affected customers via E-mail and/or FedEx . The notification identified the effective product, problem and actions to be taken. Customers were instructed to: Inspect inventory and locate any unused affected devices, cease distribution and use of those products, quarantine them immediately, complete the last two columns in the Inventory Return Certification Form, and return any affected product to the address provided. For questions call 901-396-2121 |
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| Quantity in Commerce | 601 units |
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| Distribution | Worldwide Distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = JDS
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