Encore Medical, LP: Medical Device Recall in 2025 - (Recall #: Z-0766-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

Product Classification:

Class II

Date Initiated: December 18, 2024

Date Posted: January 1, 2025

Recall Number: Z-0766-2025

Event ID: 96019

Reason for Recall:

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

Status: Ongoing

Product Quantity: 33

Code Information:

REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086

Distribution Pattern:

US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.

Voluntary or Mandated:

Voluntary: Firm initiated