Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. is recalling 89,050 Exactech Connexion GXL acetabular polyethylene liners distributed nationwide. These liners, used in Acumatch GXL 15 Degree Liner (32mm) and Novation GXL Liner, Lipped Ant (32mm) systems, pose a risk of edge-loading and premature prosthesis wear in certain patients who have specific implant configurations and surgical implant positioning. The recall affects all serial numbers across multiple UDI-DI product codes.
The source 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.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Reason for recall: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. Distribution: Distribution US nationwide. Quantity: 89,050 total Lot/code info: All serial numbers. UDI-DI numbers: 10885862023247, 10885862023254, 10885862023261, 10885862023278, 10885862207029, 10885862023315, 10885862023322, 10885862023339, 10885862023346, 10885862303325, 10885862303417, 10885862303424, 10885862303431, 10885862303448
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.