Recall Z-2879-2018 · HWC Screw, Fixation, Bone
In2bones USA, LLC
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.
| Date | Jul 16, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | In2Bones sent a Medical Device Recall letter dated July 18, 2018 to affected customers (agents and hospitals). The letter identified the affected product, problem and actions to be taken. The Agent notice requested the consignee to inform and distribute the notice to all relevant person within the organization. The firm is seeking the return of the products The notice to the hospitals and healthcare professionals explained the problem and recommended that patients be monitored for any adverse events within the normal standard of practice. For questions contact Quality and Regulatory Affair |
| Quantity | 47 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163293 | Colink Plating System In2bones USA, LLC, May 5, 2017 |