Encore Medical recalls EMPOWR 3D Knee TIBIAL INSERT E-PLUS model 342-16-707 with incorrect size or side labeling. This may lead to improper implant use during knee replacement surgery.
Knee implants contain incorrect labeling (size and/or side incorrect)
Encore Medical is recalling EMPOWR 3D Knee TIBIAL INSERT E-PLUS model 342-16-707 due to incorrect labeling of size or side. This could cause improper implant use during knee replacement surgery, potentially affecting surgical outcomes.
The knee implant has incorrect labeling for size or side, which could lead to improper implant placement during surgery. This might cause complications like misalignment or incorrect joint function after knee replacement.
Patients who received this knee implant during surgery are affected. Surgeons and medical staff who used the recalled model during procedures are most at risk.
Check for the model number 342-16-707 on the implant packaging or device. The product was sold with lot codes 161T1053 and 161T1054.
Verify the size and side labeling on the implant matches the product specifications.
The implant has incorrect labeling for size or side, which could lead to improper use during knee replacement surgery.
Check the labeling on the implant to ensure it matches the product specifications. Contact your surgeon for guidance.
The recall does not provide a specific fix; the remedy is null, meaning no action is required beyond checking labeling.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2286-2025 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-2286-2025 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.
