It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Reason for recall: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN. Quantity: 155 units Lot/code info: UDI-DI: 00889024635746; Lot Numbers:66782843 66782840 66873137
00889024635746
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.