The Recall Desk

FDA (Devices) recall action 79875

Smith & Nephew, Inc. recalled 4 products on 2018-05-30

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-05-30
Critical
0
Units
135

Why these products were recalled

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

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.

1–4 of 4

  • LowFDA (Devices)··2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 47 units of Legion CR XLPE Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 16 units of Legion CR XLPE Articular Inserts because the inner packaging pouch was inadvertently sealed with the outer pouch.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Distribution
    0 states