Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. 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, specifically Acumatch GXL 0 Degree Liner (36mm, catalog number 130-36-XX) and Novation GXL Liner Neutral (36mm), distributed nationwide in the United States. A total of 89,050 units are affected across all serial numbers. The recall was initiated due to a risk of edge-loading and premature prosthesis wear in a specific subset of patients with certain implant configurations and surgical implant positioning.
The source document does not specify a remedy or recommended action for consumers who have received these implants.
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: 10885862022202, 10885862022219, 10885862022226, 10885862207081, 10885862022233, 10885862022240, 10885862022257
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.