DJO Surgical recalls EMPOWR 3D Knee Tibial Insert e-plus (REF 341-16-711) due to packaging mixup where 12mm and 16mm knee prostheses may be swapped. Affected units include specific sizes and lot numbers.
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
DJO Surgical is recalling a specific knee implant model because packaging labels might be mixed up, potentially causing the wrong size to be used. This could lead to improper fitting and complications during surgery.
The packaging for 12mm and 16mm knee prostheses may be swapped, meaning the wrong size implant could be used. This could cause improper fitting during surgery, potentially leading to complications.
Orthopedic surgeons and hospitals using the EMPOWR 3D Knee Tibial Insert e-plus (REF 341-16-711) for left size 11, 16mm implants. Patients receiving this implant during surgery are at risk if the wrong size is used.
Check for the product name 'EMPOWR 3D Knee Tibial Insert - e-plus', reference number 341-16-711, left size 11, 16mm, CE 0086, and lot number 155T1035. The packaging may have a mix-up between 12mm and 16mm sizes.
Verify the size (12mm or 16mm) on the packaging to ensure it matches the implant being used.
The recall is for packaging mix-up risk, not an immediate safety hazard. Using the wrong size could cause improper fitting during surgery, but the risk is low.
Check for the product name 'EMPOWR 3D Knee Tibial Insert - e-plus', reference number 341-16-711, left size 11, 16mm, CE 0086, and lot number 155T1035.
The recall does not specify a remedy, so check the packaging labels to ensure the correct size is used before surgery.
We’ve drafted a message you can send DJO Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2104-2021 — DJO Surgical DJO Surgical Hello, I own a DJO Surgical that is covered by recall Z-2104-2021 from DJO Surgical. 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.
