The Recall Desk

FDA (Devices) recall action 68043

Smith & Nephew Inc recalled 2 products on 2014-05-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-05-28
Critical
0
Units
2,506

Why these products were recalled

A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2014-05-28

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207,
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-05-28

    Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Ortho
    Category
    Distribution
    0 states