Encore Medical recalls EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM model (REF 801-05-203) due to potential implant placement error during orthopedic surgery. Affected units may cause improper positioning 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, MEDIUM model (REF 801-05-203) because it can cause the knee implant to be placed 2-3mm too far back during surgery. This risk could lead to improper alignment of the implant, potentially affecting surgical outcomes.
The Locking Punch Guide in the TIBIAL PUNCH may not guide the press fit punch properly during surgery. This can cause the implant to be placed 2-3mm more posterior than intended, potentially leading to improper alignment and affecting surgical outcomes.
Orthopedic surgeons and hospitals using the EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM model (REF 801-05-203) for knee surgery are affected. Surgeons performing procedures with this specific implant component are at the highest risk.
Check for the model name 'EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM' with reference number 801-05-203. The product is non-sterile and sold in quantities of 1 for orthopedic surgery use.
Verify the model name and reference number on the product to confirm if it matches the recalled item.
The recall indicates a potential risk during surgery, but the product is not unsafe for use in general. Surgeons should follow the recall instructions to ensure proper implant placement.
The recall record does not specify a remedy, so no action is required at this time. Contact Encore Medical for further guidance if you are a surgeon using this product.
Look for the model name 'EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM' with reference number 801-05-203. The product is non-sterile and sold in quantities of 1 for orthopedic surgery.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0328-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0328-2018 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.
