FDA-Device2021-05-05Class II
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.
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
Sold states
AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
Affected count
111 units
Manufactured in
6210 N Buffalo St, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2021Don't want to check this manually?
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