Exactech recalls Connexion GXL acetabular polyethylene liners with specific catalog numbers and UDI-DI codes due to potential edge-loading causing 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 Connexion GXL acetabular polyethylene liners that may cause premature wear in specific patients with certain implant setups. This could lead to the need for additional surgeries if the hip implant wears out faster than expected.
The liners may experience edge-loading in certain patient cases, which can cause the hip implant to wear out faster than intended. This risk is tied to the specific implant configuration and surgical positioning used during the procedure.
Patients who received the recalled Connexion GXL liners during hip replacement surgery are affected. Those with specific implant configurations and surgical positioning are at higher risk for premature wear.
Check if your hip implant uses catalog numbers 104-36-XX or MCS with the specific UDI-DI numbers listed. The product is used in hip replacement surgeries and has all serial numbers.
Review your hip implant's catalog number and UDI-DI code to see if it matches the recalled items listed in the notice.
The recall does not require immediate discontinuation; you should check your implant details to see if it is affected.
The recall states a risk of premature wear but does not mention serious injury or death. The hazard is specific to certain implant configurations and surgical positioning.
Check your hip implant's catalog number and UDI-DI code against the listed numbers: 104-36-XX, MCS, and the specific UDI-DI codes provided 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-2114-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2114-2021 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.
