Exactech recalls Connexion GXL acetabular polyethylene liners with catalog numbers 138-22-XX that may cause premature prosthesis wear in certain implant configurations.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Exactech is recalling specific Connexion GXL acetabular polyethylene hip liners that could wear out prematurely in some patients due to implant positioning. This risk is limited to specific surgical configurations and does not affect all users.
The liners may experience edge-loading in certain patient anatomy and surgical setups, causing the hip joint to wear out faster than expected. This is a mechanical issue related to how the implant is positioned, not a defect in the liner itself.
Patients who received the recalled hip liners during surgery with specific implant configurations and surgical positioning. Those with different implant setups are not at risk.
Check if your hip implant uses catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, or 22mm ID. All serial numbers are affected. The UDI-DI number 10885862024503 identifies the recalled items.
Review your hip implant's catalog number, serial number, and UDI-DI number to confirm if it matches the recalled items.
No. The risk only applies to specific implant configurations and surgical positioning, not all hip implants.
Check if your liner has catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, or 22mm ID. All serial numbers are affected.
The recall does not require immediate action. Check your implant details to confirm if it's affected; no remedy is specified in the notice.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2130-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2130-2021 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.