Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

InCore Lapidus Disposable Kit 28mm Right Recalled by Nextremity Solutions Due to Product could potentially contain an undersized inner diameter...

Date: March 26, 2021
Company: Nextremity Solutions
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nextremity Solutions directly.

Affected Products

InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.

Quantity: 123 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 16 states: AL, AK, CA, IL, IN, IA, KY, MD, MI, NJ, NY, OR, PA, SC, TX, VA

Affected (16 states)Not affected

About Nextremity Solutions

Nextremity Solutions has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report