Skip to content
Recall Observatory FDA recall evidence

Device 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 in the hand, wrist, foot and ankle in both pediatric and adult patients.

Z-2880-2018

July 16, 2018

Class II

Product summary

Firm
In2bones USA, LLC
Event
Event 80618
Status
Terminated
Classification
Class II
Quantity
48 units
Official record key
device-enforcement:Z-2880-2018

Official wording

Reason: 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.

Code information: Lot Number 1704075

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.