The Recall Desk

FDA (Devices) recall action 78826

Smith & Nephew, Inc. recalled 2 products on 2018-01-31

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
2018-01-31
Critical
0
Units
4

Why these products were recalled

Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa

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)··2018-01-31

    Smith & Nephew Mini-Fragment Plating System Recalled for Labeling Error

    Smith & Nephew is recalling two units of bone plates due to incorrect labeling of the plate type.

    Product
    smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2018-01-31

    Smith & Nephew Recalls Mislabeled Mini-Fragment Bone Plating System Devices

    Smith & Nephew is recalling two units of bone plates and screws that were incorrectly labeled as one model but contained a different model.

    Product
    smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking…
    Category
    Distribution
    3 states