Nextremity Solutions recalls InCore Lapidus 28mm Left kit (part IC-LAP-28L) due to potential undersized drill bushing that may prevent surgical procedure completion.
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
Nextremity Solutions is recalling the InCore Lapidus Disposable Kit 28mm Left (part IC-L:28L) because it might have a drill bushing that's too small. This could prevent surgeons from completing the intended foot surgery. Affected users should contact the manufacturer for details.
The drill bushing might be too small, preventing the drill bit from passing through. This could stop the surgeon from completing the foot surgery as intended. The issue is specific to the 28mm left kit model.
Surgeons using this specific surgical kit for foot procedures are most at risk. Patients who have undergone the procedure with this kit may also be affected.
Check for the part number IC-LAP-28L on the kit. The product is used for internal fixation in foot surgery (First Metatarsocuneiform arthrodesis).
Reach out to Nextremity Solutions for specific instructions on how to get the kit replaced or corrected.
The recall indicates a potential issue with the drill bushing size that could prevent surgery completion, so it's not recommended for use until resolved.
The part number is IC-LAP-28L for the 28mm Left kit.
Look for the part number IC-LAP-28L on the kit, which is used for foot surgery procedures.
We’ve drafted a message you can send Nextremity Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1500-2021 — Nextremity Solutions Nextremity Solutions Hello, I own a Nextremity Solutions that is covered by recall Z-1500-2021 from Nextremity Solutions. 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.
