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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2119-2021
Event ID88126
Event DescriptionExactech 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 TypeDevices
DistributionDistribution US nationwide.
Quantity89,050 total
Recall ReasonRisk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Device Classification20210728
Device Code InfoAll serial numbers
Center Classification Date20210722
Recall Initiation Date20210629
Recalling FirmExactech, Inc.
Initial Notification Letter
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