Recall Z-2258-2014— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2014-07-02, terminated 2019-08-20. It names one FDA 510(k) clearance: K040212. 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..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-02
- Terminated
- 2019-08-20
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.