In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking
In2Bones USA, LLC is recalling 47 CoLink Lapidus Plate XP units because right and left plates were incorrectly laser-marked.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect laser marking) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
In2Bones USA, LLC is recalling 47 units of the CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165. The recall was initiated because the products were laser marked incorrectly. Specifically, right plates were marked as left plates and left plates were marked as right plates.
The affected product is indicated for the stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of small bones in the hand, wrist, foot, and ankle. The recall covers Lot Number 1704073. Distribution was worldwide, including the United States and France.
Healthcare providers and patients should stop using the affected devices and contact In2Bones USA, LLC for further instructions.
The recalled product
- 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 bone
- Manufacturer
- In2bones USA, LLC
- Hazard
- Affected units
- 47
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 1704073
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by In2bones USA, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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