Encore Medical, LP: Medical Device Recall in 2023 - (Recall #: Z-2603-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

Product Classification:

Class II

Date Initiated: August 4, 2023

Date Posted: September 27, 2023

Recall Number: Z-2603-2023

Event ID: 92969

Reason for Recall:

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

Status: Ongoing

Product Quantity: 20

Code Information:

UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029

Distribution Pattern:

US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany

Voluntary or Mandated:

Voluntary: Firm initiated