FDA-Device2021-07-28Class II
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.
Exactech, Inc.
Hazard
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Sold states
Distribution US nationwide.
Affected count
89,050 total
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2116-2021Don't want to check this manually?
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