The Recall Desk

FDA (Devices) recall action 77413

Smith & Nephew, Inc. recalled 2 products on 2017-07-05

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
2017-07-05
Critical
0
Units
82

Why these products were recalled

The incorrect Loctite adhesive was used to assemble the impactor heads.

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

  • HighFDA (Devices)··2017-07-05

    Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-07-05

    Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
    Category
    Distribution
    1 state