FDA Device recall 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) INTERTA…

FDA Device
Class II
terminated
Published 2014-08-27

On 2014-08-27 the FDA classified a Class II recall of TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTA… by Smith And Nephew, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2258-2014
Classification	Class II
Status	terminated
Initiated	2014-07-02
Published	2014-08-27
Last updated	2026-09-13 11:53 UTC
Company	Smith And Nephew
Distribution	US

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

Reason

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.

Identifiers

code_info	TRIGEN INTERTAN 10MM X 18 CM NAIL, 125o, REF 71675201, Lot Numbers: 14CM05726, 14DM08712, 14CM12004, 14DM08713, 14… 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:

code_info

TRIGEN INTERTAN 10MM X 18 CM NAIL, 125o, REF 71675201, Lot Numbers: 14CM05726, 14DM08712, 14CM12004, 14DM08713, 14…

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:

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2258-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.