Encore Medical, LP: Medical Device Recall in 2023 - (Recall #: Z-1384-2023)

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:

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

Product Classification:

Class II

Date Initiated: February 28, 2023

Date Posted: April 19, 2023

Recall Number: Z-1384-2023

Event ID: 91906

Reason for Recall:

Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.

Status: Ongoing

Product Quantity: 29

Code Information:

REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03

Distribution Pattern:

US: TX, IN, MD, CA, KS, AL, HI, WA

Voluntary or Mandated:

Voluntary: Firm initiated