Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Reason for recall: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. Distribution: Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA 2026-00088_Initial Distribution History containing the distribution and the identification of the affected consignees. Quantity: 12 Lot/code info: Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
00889024561014
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.