Encore Medical, LP: Medical Device Recall in 2023 - (Recall #: Z-0102-2024)

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:

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Product Classification:

Class II

Date Initiated: August 22, 2023

Date Posted: October 18, 2023

Recall Number: Z-0102-2024

Event ID: 93098

Reason for Recall:

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Status: Ongoing

Product Quantity: 36

Code Information:

UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028

Distribution Pattern:

US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

Voluntary or Mandated:

Voluntary: Firm initiated