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.
Check against the official notice below — it lists the full affected range.
Nextremity Solutions has recalled the InCore Lapidus Disposable Kit 28mm Left (Part Number IC-LAP-28L), a surgical device used for internal fixation of the first metatarsocuneiform joint. The recall affects 111 units from Lot Number 168B29619A distributed across 16 states including California, Texas, New York, and Pennsylvania. The product may contain a 40mm drill bushing with an undersized inner diameter that could prevent the drill bit from passing through it, potentially preventing surgeons from completing the intended surgical procedure.
The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA Quantity: 111 units Lot/code info: Lot Number: 168B29619A UDI: 00817701020868
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.