The Recall Desk

FDA (Devices) recall action 64342

Smith & Nephew Inc recalled 2 products on 2013-03-20

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
2013-03-20
Critical
0
Units
159

Why these products were recalled

75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2013-03-20

    Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws

    Smith & Nephew is recalling 90 units of Trigen internal hex reconstruction screws because 75 mm and 80 mm lengths were packaged in incorrect boxes and labels.

    Product
    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2013-03-20

    Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws

    Smith & Nephew is recalling 69 Trigen internal hex reconstruction screws because 75 mm and 80 mm units were packaged in incorrect boxes and labels.

    Product
    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
    Category
    Distribution
    11 states