Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. has recalled Exactech Connexion GXL acetabular polyethylene liners, including Acumatch GXL 15 Degree Liner (36mm) and Novation GXL Liner (Lipped Ant) models. The recall affects approximately 89,050 devices distributed nationwide that carry specific catalog numbers and UDI-DI numbers listed in the recall notice. The devices pose a risk of edge-loading and premature prosthesis wear in certain patients who have specific implant configurations and surgical implant positioning.
The source document does not specify what actions affected consumers should take in response to this recall.
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: 10885862023384, 10885862023391, 10885862023407, 10885862023414, 10885862023421, 10885862023438, 10885862023445, 10885862303332, 10885862303455, 10885862303462, 10885862303479
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.