Encore Medical recalls EMPOWR Porous Knee System TIBIAL PUNCH, SMALL model for potential implant placement error during orthopedic surgery. Affected units may cause improper positioning of knee implants.
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 a specific knee surgery implant component due to a risk of placing the implant 2-3mm too far back. This could lead to improper knee function after surgery.
The Locking Punch Guide in this implant component does not guide the 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 specific EMPOWR Porous Knee System TIBIAL PUNCH, SMALL model (REF 801-05-202) for knee surgery procedures. The risk is primarily for surgical teams handling this exact component.
Check if you have the EMPOWR Porous Knee System TIBIAL PUNCH, SMALL model with reference number 801-05-202, non-sterile, quantity 1, sold for orthopedic surgery. Lot number 252564 is also associated with this recall.
Verify if your implant component matches the recall description: EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, non-sterile, quantity 1 for orthopedic surgery.
The Locking Punch Guide may not guide the press fit punch properly, causing the implant to be placed 2-3mm more posterior than intended during surgery.
The recalled model is EMPOWR Porous Knee System TIBIAL PUNCH, SMALL with reference number 801-05-202.
The recall record does not specify a remedy.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0327-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0327-2018 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.
