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.
Check against the official notice below — it lists the full affected range.
Nextremity Solutions is recalling the InCore Lapidus Disposable Kit 28mm Right (Part Number: IC-LAP-28R), a surgical device used for internal fixation of the first metatarsocuneiform joint. The recall affects 123 units with Lot Number 168B29619B distributed across 16 states (Alabama, Alaska, California, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, and Virginia). The product may contain a 40mm drill bushing with an undersized inner diameter that prevents the drill bit from passing through, which could prevent surgeons from completing the intended surgical procedure.
The recall record does not specify a remedy or what affected consumers should do.
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: 123 units Lot/code info: Lot Number: 168B29619B UDI: 00817701020875
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.