Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2258-2014 · Posted 2014-08-17

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJDS
Date Initiated2014-07-02
Date Terminated2019-08-20
Product Quantity601 units

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.

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

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040212TRIGEN INTERTANSmith & Nephew, Inc. · 2004-02-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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