Class II — In2bones USA, LLC
| Recalling firm | In2Bones USA, LLC |
|---|---|
| Registered facility | IN2BONES USA, LLC (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 47 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of France |
| Initiated | 2018-07-16 |
| Classified | 2018-08-21 |
| Terminated | 2019-02-22 |
| Recall number | Z-2879-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — In2bones USA, LLC (Z-2879-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80618/
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