Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. is recalling Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems, including Acumatch GXL 15 Degree Liner (28mm) and Novation GXL Liner (G0, 28mm ID) models. The recall affects approximately 89,050 units distributed nationwide across all serial numbers. These liners carry specific UDI-DI numbers ranging from 10885862023063 to 10885862303400.
The liners are being recalled because of a risk of edge-loading and premature prosthesis wear in certain patients who have specific implant configurations and surgical implant positioning. The source document does not specify a remedy or corrective 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: 10885862023063, 10885862023070, 10885862023087, 10885862023094, 10885862023100, 10885862023117, 10885862023124, 10885862023148, 10885862023155, 10885862023162, 10885862303387, 10885862303394, 10885862303400
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.