DJO EMPOWR Knee Locking Tibial Punch Guide (Ref 801-05-042) may cause implant placement 2-3mm posterior. Recalled for orthopedic surgery use.
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.
DJO EMPOWR Knee Locking Tibial Punch Guide (Ref 801-05-042) is recalled because it can place the knee implant 2-3mm too far back. This risk affects orthopedic surgery procedures.
The guide doesn't properly guide the punch during implant placement, causing the knee implant to be positioned 2-3mm further back than intended. This could lead to improper alignment of the implant, potentially affecting surgical outcomes.
Orthopedic surgeons and surgical teams using the recalled guide for knee implant procedures. The risk is highest for procedures where precise implant placement is critical.
Check for the model number 801-05-042 on the guide. The product is non-sterile and used in orthopedic surgery. Lot 252567 is the specific batch number.
Verify the model number 801-05-042 and lot number 252567 on the guide.
The recall indicates a potential risk of improper implant placement, so it should not be used until the remedy is confirmed.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
The guide may cause the knee implant to be placed 2-3mm too far back, which could impact surgical outcomes.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0326-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-0326-2018 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.
