In2bones USA, LLC: Medical Device Recall in 2018 - (Recall #: Z-2880-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 16, 2018

Date Posted: August 29, 2018

Recall Number: Z-2880-2018

Event ID: 80618

Reason for Recall:

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.

Status: Terminated

Product Quantity: 48 units

Code Information:

Lot Number 1704075

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of France

Voluntary or Mandated:

Voluntary: Firm initiated