Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2122-2021)
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 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.
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: 10885862023384, 10885862023391, 10885862023407, 10885862023414, 10885862023421, 10885862023438, 10885862023445, 10885862303332, 10885862303455, 10885862303462, 10885862303479
Distribution US nationwide.
Voluntary: Firm initiated