Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. 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, specifically Acumatch GXL 0 Degree Liners and Novation GXL Liners in 28mm size. The recall affects 89,050 total units distributed nationwide. A specific subset of patients with certain implant configurations and surgical implant positioning face a risk of edge-loading and premature prosthesis wear.
The recall involves all serial numbers of the affected liners, which can be identified by their UDI-DI numbers listed in the recall notice. The source document 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: 10885862021984, 10885862021991, 10885862022004, 10885862022011, 10885862022028, 10885862022035, 10885862022059, 10885862022066, 10885862022073
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.