The Recall Desk

FDA (Devices) recall action 80618

In2bones USA, LLC recalled 2 products on 2018-08-29

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
2018-08-29
Critical
0
Units
95

Why these products were recalled

CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.

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

  • ModerateFDA (Devices)··2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 47 CoLink Lapidus Plate XP units because right and left plates were incorrectly laser-marked.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bone
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 48 units of CoLink Lapidus Plates because right and left plates were laser marked incorrectly.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones
    Category
    Distribution
    0 states