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Nextremity Solutions recalls InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct int

Recalled May 5, 2021 · FDA recall Z-1500-2021 · Nextremity Solutions

Hazard
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 · FDA Class II
Units
111 units
Sold at
AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

Description

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

Product
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Manufacturer(s)
Nextremity Solutions

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Nextremity Solutions recalls InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct int | RecallWatchUSA