Device recall
Z-2879-2018: CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones…
FDA device recall · Class II · In2bones USA, LLC
Key facts
| Recall number (Z-number) | Z-2879-2018 |
|---|---|
| Recall event | 80618 |
| 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… |
| Product code | HWC |
| Recalling firm | In2bones USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 22, 2019 |
| 510(k) numbers | K163293 |
| FEI number | 3011580264 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database