DJO Surgical recalls EMPOWR 3D Knee Tibial Insert e-plus models with packaging mixup risk. Incorrect size knee prostheses may be shipped. Check your product label for serial number and size.
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 specific models of knee inserts due to a packaging mix-up. This could mean customers receive the wrong size prosthesis, which might not fit properly and cause complications during surgery.
The packaging mix-up means that 12mm knee prosthesis packaging might contain 16mm prosthesis and vice versa. Using the wrong size could lead to improper fit during surgery, potentially causing complications.
Patients scheduled for knee surgery using the recalled EMPO: 341-12-711, Left Size 11, 12mm models. Surgeons and medical staff handling these implants are most at risk.
Check your product label for the serial number (01)00888912166980 and lot number 115T1035. The product is a left knee insert size 11 with 12mm dimensions.
Look for the serial number (01)00888912166980 and lot number 115T1035 on the packaging.
The recalled model is DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Size 11, 12mm.
Check your product label for the serial number (01)00888912166980 and lot number 115T1035. The product is a left knee insert size 11 with 12mm dimensions.
The recall record does not specify a remedy, so no action is required beyond checking your product label.
We’ve drafted a message you can send DJO Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2103-2021 — DJO Surgical DJO Surgical Hello, I own a DJO Surgical that is covered by recall Z-2103-2021 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.
