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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2258-2014

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

Publicado el 27 de agosto de 2014 · Inicio del retiro: 2 de julio de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Smith & Nephew, Inc.
Distribuidor
Worldwide Distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL
Lote
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, LEF
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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