Exactech recalls Connexion GXL acetabular polyethylene liners with catalog numbers 104-28-XX and MCS for possible premature wear in specific 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 Connexion GXL acetabular polyethylene liners that may cause premature wear in certain hip implant setups. This could lead to the need for additional surgeries if the liners wear out faster than expected.
The liners may experience edge-loading in certain patient cases, causing them to wear out faster than intended. This could lead to the need for additional hip surgeries if the liners fail prematurely.
Patients who received Exactech Connexion GXL acetabular polyethylene liners with catalog numbers 104-28-XX or MCS. Those with specific implant configurations and surgical positioning are most at risk.
Check if your hip implant uses Exactech Connexion GXL acetabular polyethylene liners with catalog numbers 104-28-XX or MCS. Look for specific UDI-DI numbers listed in the recall notice.
Review your hip implant's catalog number and UDI-DI numbers to see if they match the recalled items listed in the notice.
No, the recall does not require stopping use. The risk is specific to certain implant configurations and surgical positioning.
The recall does not specify a remedy, so you do not need to take any action unless your surgeon advises otherwise.
Check the catalog numbers (104-28-XX or MCS) and UDI-DI numbers listed in the recall notice.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2112-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2112-2021 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.
