CoLink — Class II medical device recall Z-2880-2018
Terminated recall by In2bones USA, LLC, reported 2018-08-29, distributed nationwide. CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were
| Recall number | Z-2880-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2bones USA, LLC, Memphis, TN, United States |
| Recall initiated | 2018-07-16 |
| Classified | 2018-08-21 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2019-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 48 units |
| Lot numbers | 1704075 |
| Model numbers | IN2BONES, P40, ST265 |
Product
CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2880-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.