Encore Medical recalls EMPOWR 3D knee tibial inserts due to packaging errors that may lead to incorrect product selection and revision surgery.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Encore Medical is recalling EMPOWR 3D knee tibial inserts that may be packaged with the wrong components. Using these could lead to needing revision surgery if the incorrect product is selected.
The packaging discrepancy means the wrong tibial inserts might be included in the product package. If the incorrect product is used during surgery, it could lead to needing revision surgery.
Patients who received the EMPOWR 3D knee tibial insert model 341-12-711 from Encore Medical are affected. Those at highest risk are patients who have undergone knee replacement surgery and may require revision.
Check for the model number 341-12-711 on the packaging. The product was sold with lot code 115T1077 and software version NA.
Look for the model number 341-12-711 and lot code 115T1077 on the packaging to confirm if it's the recalled item.
The recall is due to packaging discrepancies that could result in the incorrect tibial inserts being packaged, potentially requiring revision surgery.
Check the model number and lot code on the packaging. If it matches the recalled item, contact Encore Medical for further instructions.
The recall states that using the incorrect product could lead to revision surgery, but there is no mention of immediate injury risks.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2126-2025 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-2126-2025 from Encore Medical. 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.
