Device product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
Z-2127-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 88126
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89,050 total
- Official record key
device-enforcement:Z-2127-2021
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: 10885862024275, 10885862024282, 10885862024299, 10885862024305, 10885862024312
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.