RecallRadar

FDA Device recall Z-2120-2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22…

On 2021-07-28 the FDA classified a Class II recall of Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22… by Exactech, citing risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2120-2021
ClassificationClass II
Statusongoing
Initiated2021-06-29
Published2021-07-28
Last updated2026-09-13 11:56 UTC
CompanyExactech
DistributionUS

Product

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.

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.

Identifiers

code_infoAll serial numbers. UDI-DI numbers: 10885862303370, 10885862022967

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2120-2021%22

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