Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 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 and Novation GXL models. A total of 89,050 units with various catalog numbers and UDI-DI identifiers were distributed nationwide. The recall addresses a risk that certain implant configurations combined with specific surgical positioning may cause edge-loading and premature wear of the prosthesis in some patients.
The recall affects all serial numbers of the affected liners. The source document does not specify any remedy or corrective action that affected consumers should take.
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: 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.