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: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906
00889024635647
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.