Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. has recalled Exaction Connexion GXL acetabular polyethylene liners used in hip implant systems, specifically catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG, and MCS GXL Liner 5/15 DEG. The recall affects approximately 89,050 units distributed nationwide and involves all serial numbers associated with the recalled products.
The recall was issued because of a risk of edge-loading and premature prosthesis wear that is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. The source document does not specify a remedy or instructions 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: 10885862013491, 10885862013507, 10885862013514, 10885862013521, 10885862013538, 10885862013545, 10885862013569, 10885862013576, 10885862013583
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.