Exactech, Inc.: Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm

Is my product affected?

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.

• UPC 10885862022097
• UPC 10885862022103
• UPC 10885862022110
• UPC 10885862022127
• UPC 10885862207074
• UPC 10885862022165
• UPC 10885862022172
• UPC 10885862022189
• UPC 10885862022196

Check against the official notice below — it lists the full affected range.

What happened

Exactech, Inc. is recalling Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems, specifically Acumatch GXL 0 Degree Liner and Novation GXL Liner (Neutral) in 32mm size. The recall affects 89,050 units distributed nationwide 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 record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Details from the source

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: 10885862022097, 10885862022103, 10885862022110, 10885862022127, 10885862207074, 10885862022165, 10885862022172, 10885862022189, 10885862022196

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.2021-06-29
• 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.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.2021-06-29

All FDA (Device enforcement) recalls