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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN(R) INTERTAN(TM) NAIL

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  Class 2 Device Recall TRIGEN(R) INTERTAN(TM) NAIL see related information
Date Initiated by Firm July 02, 2014
Date Posted August 17, 2014
Recall Status1 Terminated 3 on August 20, 2019
Recall Number Z-2258-2014
Recall Event ID 68792
510(K)Number K040212  
Product Classification Nail, fixation, bone - Product Code JDS
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
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
For Additional Information Contact Joe Metzger
978-749-1330
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.
FDA Determined
Cause 2		 Under Investigation by firm
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
Quantity in Commerce 601 units
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
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 = JDS and Original Applicant = SMITH & NEPHEW, INC.
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