Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2131-2021)
See the recall detail below. You can also see other recalls from the same firm in 2021.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Class II
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
All serial numbers. UDI-DI numbers: 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671
Distribution US nationwide.
Voluntary: Firm initiated