Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner,
Check against the official notice below — it lists the full affected range.
Exactech, Inc. is recalling Exactech Connexion GXL acetabular polyethylene liners distributed nationwide in the United States. The recall affects 89,050 units across multiple catalog numbers and sizes (32mm, 36mm, and 40mm), with all serial numbers potentially affected. These liners are used as components in hip replacement systems and pose a risk of edge-loading and premature prosthesis wear in a specific subset of patients who have certain implant configurations and surgical implant positioning.
The source document does not specify a remedy or recommended course of 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: 138-32-XX: 10885862024732, 10885862024749, 10885862024756, 10885862024763, 10885862024770. 138-36-XX: 10885862024817, 10885862024824, 10885862024831, 10885862024848, 10885862024886, 10885862024893, 10885862024909, 10885862024916. 138-40-XX: 10885862208804, 10885862208811, 10885862208828.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.