Exactech recalls Connexion GXL acetabular polyethylene liners for hip implants with specific catalog numbers and UDI-DI codes due to potential edge-loading causing premature prosthesis wear in certain patient 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 cause premature wear in certain patients due to improper implant positioning. This risk is limited to specific implant configurations and surgical placements, not all users.
The liners could experience edge-loading in specific patient cases, leading to faster wear of the hip implant. This happens when the implant is positioned in a way that causes uneven pressure on the liner's edges, especially in certain body types or surgical techniques.
Patients who received the recalled Connexion GXL hip liners with specific catalog numbers and UDI-DI codes during hip surgery are most at risk. The risk applies only to a specific subset of patients with certain implant configurations and surgical placements.
Check if your hip implant uses the Connexion GXL acetabular polyethylene liners with catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm, or Novation GXL Liners (28mm ID or lipped versions). Also verify your UDI-DI numbers match the listed codes.
Review your hip implant's catalog number and UDI-DI code to see if they match the recalled items listed in the notice.
No, the recall does not require stopping use. The risk is limited to specific implant configurations and surgical placements, not all users.
The recall does not include a remedy for returning or discarding the liners. You should check your implant details to see if you are affected.
Check your hip implant's catalog number and UDI-DI code against the listed numbers: 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm, Novation GXL Liners (28mm ID or lipped versions), and the specific UDI-DI codes provided.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2121-2021 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.
