In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking
In2Bones USA, LLC is recalling 48 units of CoLink Lapidus Plates because right and left plates were laser marked incorrectly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 the hazard involves incorrect laser marking (labeling error) without reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
In2Bones USA, LLC is recalling 48 units of CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265. The recall involves Lot Number 1704075, which was distributed nationwide in the US and in France.
The recall was initiated because the CoLink(TM) Lapidus Plate +2mm Right and Left plates 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.
The 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.
The recalled product
- 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…
- Manufacturer
- In2bones USA, LLC
- Hazard
- Affected units
- 48
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 1704075
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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