Nextremity Solutions recalls InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct i…

Recall date

March 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1501-2021

FDA classification

Class II

Brand / firm

Nextremity Solutions

Sold / distributed

AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.