In2Bones recalls one unit of CoLink Lapid: Laser marking error may cause confusion between left and right plates. No action needed as it's a labeling issue.
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.
In2Bones is recalling one specific unit of the CoLink Lapidus Plate XP +2 mm Left model due to a laser marking error. This mistake could lead to using the wrong plate side, but it doesn't pose a safety risk.
The laser marking on the plates was incorrect, meaning the left plates were marked as right and vice versa. This could cause confusion during use but does not affect the plate's function or safety.
Patients using the CoLink Lapidus Plate XP +2 mm Left model (REF P40 ST265) from the In2Bones USA LLC manufacturer. The risk is low as it's a labeling error, not a safety hazard.
Check for the model name 'CoLink Lapidus Plate XP +2 mm Left', reference number 'P40 ST265', and lot number '1704075'. This specific unit was recalled due to the marking error.
Look for the model name, reference number, and lot number on the product to confirm if it matches the recalled unit.
No, this is a labeling error that does not affect safety. The recall is for identification purposes only.
No action is required as the error is not a safety hazard.
Check for the model name 'CoLink Lapidus Plate XP +2 mm Left', reference number 'P40 ST265', and lot number '1704075'.
We’ve drafted a message you can send In2Bones to request your refund or repair — edit it as you like.
Subject: Recall Z-2880-2018 — In2Bones In2Bones Hello, I own a In2Bones that is covered by recall Z-2880-2018 from In2Bones. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
