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Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GX
Recalled July 28, 2021 · FDA recall Z-2112-2021 · Exactech
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. · FDA Class II
Units
89,050 total
Sold at
Distribution US nationwide.
Description
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →