Device product
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.
Z-2131-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 88126
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89,050 total
- Official record key
device-enforcement:Z-2131-2021
Official wording
Reason: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Code information: All serial numbers. UDI-DI numbers: 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671
Distribution pattern: Distribution US nationwide.
Derived failure modes
-
Unknown
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.