FDAClass IIAugust 29, 2018

CoLink(TM) Lapidus Plate XP recall

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…

Why was CoLink(TM) Lapidus Plate XP recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 1704073

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…
Recalling firm
In2bones USA, LLC
Quantity
47 units
Distribution
Worldwide Distribution - US Nationwide and the countries of France
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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