Device 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 bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Z-2879-2018
Product summary
- Event
- Event 80618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47 units
- Official record key
device-enforcement:Z-2879-2018
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 1704073
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of France
Derived failure modes
-
Unknown
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.