Z-2879-2018 Class II Terminated
FDA device recall Z-2879-2018 was initiated by In2bones USA, LLC on July 16, 2018 and is designated Class II. 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. The recall status is terminated (terminated February 22, 2019). Affected quantity: 47 units.
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