medical Class II Updated 2021-07-28

Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used i

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers. UDI-DI numbers: 10885862023063, 10885862023070, 10885862023087, 10885862023094, 10885862023100, 10885862023117, 10885862023124, 10885862023148, 10885862023155, 10885862023162, 10885862303387, 10885862303394, 10885862303400
View official government recall

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