DJO Surgical recalls Empowr Knee and Universal Tibia Baseplate models due to unsterilized components that may cause infection after implant. Affected units have specific UDI-DI/Lot/Expiration codes.
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
DJO Surgical is recalling Empowr Knee and Universal Tibia Baseplate models because their components weren't properly sterilized before shipping. If implanted, this could lead to infections requiring treatment, monitoring, and possible revision surgery.
The orthopedic device components were not sterilized properly before being shipped. If these components are implanted, they could cause infections that might need antibiotics, additional monitoring, and possibly revision surgery.
Patients who have received the Empowr Knee or Universal Tibia Baseplate implants with the specific UDI-DI/Lot/Expiration codes listed are affected. Those with the recalled models are at risk of infection if the device is implanted.
Check for the UDI-DI/Lot/Expiration code 00190446258032/308V1112 on the product with the expiration date May 25, 2029. The recalled models are Empowr Knee and Universal Tibia Baseplate, 6R, REF: 352-02-106.
Look for the UDI-DI/Lot/Expiration code 00190446258032/308V1112 with expiration May 25, 2029 on the Empowr Knee or Universal Tibia Baseplate, 6R model.
The orthopedic device components were not subjected to final sterilization before shipment, which could lead to infections if implanted.
Check for the UDI-DI/Lot/Expiration code 00190446258032/308V1112 with expiration May 25, 2029. If you have the recalled model, contact DJO Surgical for further instructions.
The hazard is infection risk after implantation, which may require treatment and revision surgery, but does not cause immediate serious injury in normal use.
We’ve drafted a message you can send DJO Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2603-2023 — DJO Surgical DJO Surgical Hello, I own a DJO Surgical that is covered by recall Z-2603-2023 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.
