Exactech, Inc. Recall 88126
Description: Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
Exactech, Inc. Recall 88126 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2119-2021 |
Event ID | 88126 |
Event Description | Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component. |
Product Type | Devices |
Distribution | Distribution US nationwide. |
Quantity | 89,050 total |
Recall 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. |
Device Classification | 20210728 |
Device Code Info | All serial numbers |
Center Classification Date | 20210722 |
Recall Initiation Date | 20210629 |
Recalling Firm | Exactech, Inc. |
Initial Notification | Letter |
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