Encore Medical recalls EMPOWR Porous Knee System TIBIAL PUNCH, LARGE model for potential improper implant placement during orthopedic surgery. Affected units may cause misalignment of the knee implant.
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Encore Medical is recalling its EMPOWR Porous Knee System TIBIAL PUNCH, LARGE model (REF 801-05-204) because it can cause the knee implant to be placed 2-3mm too far back during surgery. This misalignment could lead to improper knee function after surgery.
The Locking Punch Guide in this model does not guide the large press fit punch properly. This can cause the knee implant to be placed 2-3mm more posterior than intended during surgery, potentially leading to improper knee function.
Orthopedic surgeons and hospitals using the EMPOWR Porous Knee System TIBIAL PUNCH, LARGE model (REF 801-05-204) for knee surgery are affected. Surgeons using this specific model during procedures are at risk of implant misplacement.
Check for the model name 'EMPOWR Porous Knee System TIBIAL PUNCH, LARGE' with reference number 801-05-204. The product is non-sterile and sold in quantities of 1 for orthopedic surgery use.
Verify the model number and reference number on the product label to confirm if it matches the recalled item.
The recall indicates a potential risk of improper implant placement during surgery, so it is not recommended for use without checking the recall status.
The recall does not specify a remedy, so contact Encore Medical directly for guidance.
Look for the model name 'EMPOWR Porous Knee System TIBIAL PUNCH, LARGE' with reference number 801-05-204 on the product label.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0329-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0329-2018 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.
