Nextremity Solutions recalls InCore Lapid: 28mm Right kit 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 a specific surgical kit for foot procedures because it might have a drill bushing that's too small, preventing surgeons from completing the surgery as intended. This could lead to incomplete procedures and potential complications.
The kit's drill bushing might be undersized, which could prevent the drill bit from passing through. This would stop the surgeon from completing the intended surgical procedure, potentially leading to incomplete treatments.
Surgeons performing First Metatarsocuneiform arthrodesis procedures using this specific kit are affected. Patients undergoing this surgery are at risk if the kit is used.
Check for the part number IC-LAP-28R on the kit. The kit is intended for internal fixation of First Metatarsocuneiform arthrodesis procedures.
Verify the part number IC-LAP-28R on the kit to confirm if it's affected.
The kit might have an undersized drill bushing that prevents the drill bit from passing through, which could stop the surgeon from completing the surgery as intended.
The official recall notice does not specify a remedy or action steps for affected kits.
The recall indicates a potential risk that could prevent the surgery from being completed, so it is not recommended for use until the recall is addressed.
We’ve drafted a message you can send Nextremity Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1501-2021 — Nextremity Solutions Nextremity Solutions Hello, I own a Nextremity Solutions that is covered by recall Z-1501-2021 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.
