Device product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.
Z-2116-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 88126
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89,050 total
- Official record key
device-enforcement:Z-2116-2021
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: 10885862021984, 10885862021991, 10885862022004, 10885862022011, 10885862022028, 10885862022035, 10885862022059, 10885862022066, 10885862022073
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.