Z-2879-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- July 16, 2018
- Termination Date
- February 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
Product Description
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 bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of France
Code Information
Lot Number 1704073