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 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. 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: 10885862023247, 10885862023254, 10885862023261, 10885862023278, 10885862207029, 10885862023315, 10885862023322, 10885862023339, 10885862023346, 10885862303325, 10885862303417, 10885862303424, 10885862303431, 10885862303448
View official government recall

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